Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Paclitaxel

Albumin-Bound Paclitaxel

Liver Extracts

Tubulin Modulators

Antimitotic Agents

Dose escalation beginning Day 1, Cycle 2 dose level 180 mg/m\^2 for maximum tolerated dose (MTD) of Hepatic Arterial Infusion of Abraxane (HAI Abraxane) following same dose intravenous Abraxane in Cycle 1 of 21 day cycle.

HAI Abraxane dose expansion at MTD or dose level 3 (260 mg/m\^2) if MTD not defined.

Escalating doses (beginning dose 180 mg/m\^2) starting Day 1, Cycle 2 and later via hepatic arterial infusion (HAI) following IV Abraxane in Day 1, Cycle 1 for 21 day cycles.

HAI Abraxane

On each day of treatment for Cycles 2-4, hepatic artery catheter placement completed by interventional radiology.

Hepatic Artery Catheter

Intravenous (IV) Abraxane only in Cycle 1 (up to Dose Level 4 of 260 mg/m\^2), infused over 60 minutes or 4 hours Day 1 of 21 day cycle.

IV Abraxane

Siqing Fu, MD, PHD

The goal of this clinical research study is find the highest tolerated dose of Abraxane (nab-paclitaxel) that can be given directly into the liver of patients with advanced cancer that has spread to the liver.

The Study Drug:

Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cells to die.

Giving nab-paclitaxel directly into the liver may allow a higher dose of the drug to be given, while avoiding some of the side effects that occur when high doses of chemotherapy are given other ways (for example, by vein into an arm).

Study Drug Dose Level:

If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you joined this study. Up to 9 groups of 6 participants will be enrolled in Part 1 of the study, and up to 18 participants will be enrolled in Part 2. If you are enrolled in Part 1, the dose of the study drug you receive will depend on when you joined this study. The first group of participants will receive the lowest dose level of the study drug. Each new group will receive a higher dose of the study drug than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the study drug is found. If you are enrolled in Part 2, you will receive the study drug at the highest dose that was tolerated in the Part 1 portion.

Study Drug Administration:

The study drug will be given on Day 1 of "cycles" that are 21 days long. In Cycle 1 only, some participants may receive the study drug through a vein in their arm. The infusion will last 60 minutes. In Cycles 2 and later, you will receive the study drug through a catheter (a thin plastic tube). Each time the catheter is placed, you will be admitted to the hospital.

The doctor who performs the catheter placement procedure will explain it to you in more detail, and you will be asked to sign a separate consent form that describes the procedure and its risks in more detail.

You will be taken to the Interventional Radiology area, and the catheter will be placed in a blood vessel in your groin area, on the right side of your body. The catheter will be advanced to the liver. The catheter will be carefully taped in order to prevent it from moving or coming out while you are receiving the study drug. You will be on bedrest for the entire time that the catheter is in place.

After having the catheter inserted, you will be taken to the Nuclear Medicine area, and a test called "flow study" will be performed in order to confirm that the catheter is in the right place. The doctor who performs this test will explain it to you in more detail, and you will be asked to sign a separate consent form that describes the procedure and its risks in more detail.

After you return to your room, you will receive the study drug through the catheter over 60 minutes or 4 hours, depending on when you enroll. You will be asked to lie flat on your back while receiving the study drug.

The catheter will be removed by someone experienced in the procedure. It will be removed right after your study drug dose is complete. While the catheter is being removed, the study staff will apply pressure to your groin area for 15 minutes in order to stop the bleeding.

You will repeat this procedure once every 21 days. The catheter will be placed and removed each time.

Study Procedures and Tests:

Once a week, including before each dose of the study drug, blood (about 2 teaspoons) will be drawn for routine tests. These blood draws can be done at M. D. Anderson or somewhere else, if there is a place that is more convenient for you.

Once during each cycle (on a day when you are already in clinic), you will have a physical exam, including measurement of height, weight, and vital signs. Urine will be collected for routine tests.

At the end of every 3 cycles, you will have scans performed (the same type of scans as at screening) to check the status of the disease. If the study doctor feels it is appropriate, you may have blood drawn (about 1 teaspoon) to look for tumor markers.

Blood Testing for Research Purposes:

In Cycles 1 and 2, additional blood will be drawn for pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body at different time points. For participants receiving the study drug over 60 minutes, this blood (about 1 teaspoon each time) will be drawn on Day 1 (before you receive the study drug and at 5, 10, 20 and 40 minutes after the start of the dose, and then at 1, 1½, 2, 3, 4, and 6 hours after the start of the dose). Blood will also be drawn on Day 2 (24 hours after the start of the dose).

For participants receiving the study drug over 4 hours, this blood (about 1 teaspoon each time) will be drawn on Day 1 (before you receive the study drug and at 30 minutes after the start of the dose, and then at 1, 2, 3, 4, 4 ½, 5, 6, 7, and 9 hours after the start of the dose). Blood will also be drawn on Day 2 (24 hours after the start of the dose).

Length of Study Participation:

You will continue to receive the study drug once every 21 days. If the disease gets worse or intolerable side effects occur, you will be taken off the study drug.

End-of-Study Visit:

After your last dose of the study drug, you will have an end-of-study visit. At this visit, the following procedures will be performed:

* You will have a physical exam, including measurement of weight and vital signs.
* Blood (about 2 tablespoons) and urine will be collected for routine tests.
* To check the status of the disease, you will have scans performed (the same types of scans that you had before).
* If the study doctor feels it is appropriate, you may have blood drawn (about 1 teaspoon) to look for tumor markers.

This is an investigational study. Nab-paclitaxel is commercially available and FDA approved for use in breast cancer and for "systemic" use only. Systemic therapies affect the body as a whole. It is investigational to give nab-paclitaxel directly into the liver and to give it to patients with advanced cancer. At this time, giving it directly into the liver of patients with advanced cancer is only being done in research.

Up to 56 patients will take part in this study. All will be enrolled at M. D. Anderson.

Hepatic Arterial Infusion (HAI) of Abraxane

Phase I Trial of Hepatic Arterial Infusion of Abraxane With a Pharmacokinetic Study in Advanced Solid Cancer Patients With Predominant Hepatic Metastases

MTD is highest dose level in which 6 patients with at most 1 patient experiencing a dose limiting toxicity (DLT). Dose escalation continues until DLT is defined or until dose level 4 is completed. DLT defined during first cycle of treatment.

National Comprehensive Cancer Network

M.D. Anderson Cancer Center

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Micronutrients

Vitamins

Dexamethasone

Leucovorin

Fluorouracil

Oxaliplatin

Dexamethasone acetate

Floxuridine

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antimetabolites

Immunosuppressive Agents

Immunologic Factors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

Patients will receive mFOLFOX6 every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15.

Patients will receive mFOLFOX6+HAI every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15. 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

This will be repeated on Day 1 of each 28-day cycle. FUDR will be administered through a 14-day continuous infusion with the HAI pump.

mFOLFOX6

Patients will receive HAI every 28 days: 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.

This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump.

Yu-hong Li, MD, Ph D

The primary objective of this study is to determine whether systemic chemotherapy combined with hepatic arterial infusion with floxuridine and dexamethasone can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.

Recent studies and our experience have proved the efficacy and safety of systemic chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone in patients with initially unresectable colorectal liver metastasis. However, most of them are retrospective studies, phase I or II clinical researches, which could not provide high-level evidence. Therefore, we designed this study to determine whether systemic chemotherapy combined with HAI can increase the complete resection rate (R0) and improve the overall survival in patients with initially unresectable colorectal liver metastasis.

A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis

Systemic Chemotherapy With or Without Hepatic Arterial Infusion With Floxuridine in Patients With Initially Unresectable Colorectal Liver Metastasis: A Prospective, Randomised, Controlled Study

Yuhong Li

MD, Ph D

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

chemotherapy ± target therapy

Jianmin Xu, PhD

To date no prospective trials have been completed that demonstrated whether HAI is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversional resection rates and survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine conversional resection rates and survival for patients with colorectal cancer liver metastasis are treated with HAI plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.

Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM

A Prospective, Randomized, One-center Study Comparing Hepatic Arterial Infusion Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Colorectal Cancer Liver Metastases

Fudan University

Prof.

Bevacizumab

Irinotecan

Antibodies

Antibodies, Monoclonal

Cetuximab

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Topoisomerase I Inhibitors

Enzyme Inhibitors

Group 2 = Irinotecan, Bevacizumab + Oxaliplatin

Group 3 = Irinotecan, Bevacizumab + Cetuximab

Starting dose of 35 mg/m\^2 given through the catheter into your liver artery (hepatic artery infusion - HAI), continuously for 72 hours (Days 1 through 2 of each cycle).

10 mg/Kg by vein on Days 1 and 15 of every 28 day cycle, over 90 minutes first cycle and over 30-60 minutes subsequent cycles.

Starting dose 60 mg/m\^2 by vein over 2 hours on Days 1 and 15 of every cycle.

500 mg/m\^2 by vein on Days 1 and 15 of every cycle. The first time given over 2 hours, all other cycles over 1 hour.

Apostolia M. Tsimberidou, MD, PhD

The goal of this clinical research study is to learn the highest tolerable dose of irinotecan that can be given directly into the liver, in combination with other drugs given by vein.

The other drug combinations given by vein include bevacizumab alone, bevacizumab plus oxaliplatin, and bevacizumab plus cetuximab.

This will be tested in patients with advanced solid tumors that have spread to the liver. The safety of these drug combinations will also be studied.

The Study Drugs:

Irinotecan is designed to stop cancer cells from making new DNA (the genetic material of cells). This may cause cancer cells to die.

Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels that supply nutrients necessary for tumor growth.

Oxaliplatin is designed to block new cancer cells from growing.

Cetuximab is designed to prevent or slow down the growth of cancer cells by blocking proteins inside cancer cells.

Study Arms and Dose Levels:

If you are found to be eligible to take part in this study, your doctor will assign you to a study arm. Your study arm will depend on the type of cancer, your Kirsten rat sarcoma (KRAS) test result (if applicable), and the drugs you have taken in the past.

* If you are in Arm A, you will receive irinotecan and bevacizumab.
* If you are in Arm B, you will receive irinotecan, bevacizumab, and oxaliplatin.
* If you are in Arm C, you will receive irinotecan, bevacizumab, and cetuximab.

The dose that you receive will depend on when you are enrolled in this study and the safety data that is available at that time. The first set of 3-6 participants to join each study arm will receive the lowest dose of the drug combination. The next set of 3-6 participants will receive a higher dose of the drug combination. Each new set of participants will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the drug combinations is found.

Once the highest tolerable dose is found for each arm, 14 participants with the tumor type that has responded well to a particular study drug combination will receive the study drugs at that dose level. These participants will be in the "expansion" arms.

Catheter Placement:

You will be hospitalized to receive the study drug combination. The morning after you enter the hospital, you will have a catheter placed in your right groin area. A catheter is a sterile flexible tube. It will be placed into a large artery (the blood vessel that carries blood to your liver) while the area is numbed with local anesthetic. Your doctor will explain this procedure to you in more detail, and you will be asked to sign a separate consent form for it.

After you return to your room, you will receive irinotecan as described below.

Study "cycles" will be repeated every 28 days. The catheter will be placed and removed during each cycle. Each time, you will lie in bed for the entire time that the catheter is in place. While the catheter is being removed, the study staff will apply pressure to your groin area for 15 minutes to stop the bleeding.

Study Drug Administration:

Irinotecan will be given through the catheter into your liver artery, continuously for 48hours (Days 1 through 2 of each cycle). Before every irinotecan dose, you will also receive drugs by vein to lower the risk of nausea, if your doctor thinks this is needed for routine care.

Bevacizumab will be given by vein once every 2 weeks. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, all other bevacizumab doses will be given over 30-60 minutes.

Oxaliplatin, if you receive it, will be given by vein over 2 hours once every 2 weeks. Before every oxaliplatin dose, you will also receive drugs by vein to lower the risk of nausea, if your doctor thinks this is needed for routine care.

Cetuximab, if you receive it, will be given by vein once every 2 weeks. The first time you receive cetuximab, it will be given over 2 hours. All other cetuximab doses will be given over 1 hour.

If you do not tolerate the study drug combination well, the doses that you receive may be lowered. If you experience certain side effects, your study drug doses may be delayed and the study cycle may be longer than 28 days.

You will be given standard drugs (heparin and diphenhydramine) to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks.

Study Visits:

You will be in the hospital for about 5-7 days at the beginning of every cycle, until you recover from side effects that may occur. You will be seen by a doctor or "advanced practice" nurse every day while you are in the hospital.

At the beginning of each cycle and then once a week during each cycle, blood (about 1 tablespoon) will be drawn for routine tests. At the beginning of each cycle and then once every 4 weeks (or earlier if needed), you will have a physical exam.

You will have scans such as a chest x-ray, CT, MRI, and/or PET scan after every 2 cycles (8 weeks) or earlier if the study doctor thinks it is in your best interest, or the cancer gets worse. These scans are to check the status of the disease. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form.

Additional Tests/Procedures for Some Participants:

If you experience severe diarrhea and/or low white blood cell counts while on this study, blood (about 2 teaspoons) will be drawn to test your DNA to find out if you may be at a higher risk of side effects from irinotecan. If the test shows that you may have a higher risk, then you will receive irinotecan at a lower dose level.

If you are in Arm C (which as discussed above, does not include colorectal cancer patients with a KRAS mutation), a leftover sample of tumor tissue will be tested for the KRAS mutation. If no leftover tumor tissue from an earlier procedure is available, and if your KRAS status is unknown, you will have a needle biopsy of a tumor performed. The tissue will be tested for the KRAS mutation. This procedure will be done on an appropriate tumor area that is able to be biopsied, and it may or may not be the liver tumor. This will be the doctor's decision.

Length of Study:

You may stay on study for as long as the disease has not gotten worse, the cancer has not gone away completely, and you have not experienced intolerable side effects. In any of those cases, you would be taken off study.

End-of-Study Visit:

About 28 days after your last dose of study drugs, you will have an end-of-study visit. At this visit, the following tests and procedures may be performed:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 2 teaspoons) will be drawn for routine tests.
* If the doctor thinks it is needed, you will have an x-ray, CT scan, PET scan, or -MRI scan to check the status of the disease.

This is an investigational study. It is investigational to give irinotecan into a liver artery. The study drug combinations and dose levels are also investigational.

The study drugs are commercially available and FDA approved to treat the following:

* Irinotecan by vein -- colorectal cancer that is metastatic (has spread).
* Bevacizumab -- metastatic colorectal cancer, breast cancer, non small-cell lung cancer, and a type of brain cancer called glioblastoma multiforme.
* Cetuximab -- colorectal cancer, and head and neck cancer.
* Oxaliplatin -- colorectal cancer.

Up to 140 patients will take part in this study. All will be enrolled at M. D. Anderson.

HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver

A Multi-arm Phase I Trial of Hepatic Arterial Infusion of Irinotecan With 1) Systemic Bevacizumab 2) Systemic Bevacizumab and Oxaliplatin 3) Systemic Bevacizumab and Cetuximab in Patients With Advanced Cancers Metastatic to the Liver

MTD is defined as the highest dose level at which ≥ 33% of patients have a DLT if \>3 patients are treated at that dose level or \> 33% have a DLT if ≤3 patients have been treated.

DLT defined as any grade 3 or 4 non-hematologic toxicity defined in NCI CTC v3.0, even if expected and believed related to study medications (except nausea and vomiting responsive to appropriate regimens or alopecia), any grade 4 hematologic toxicity lasting 2 weeks or longer (as defined by the NCI-CTCAE), despite supportive care; any grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome; or any severe or life-threatening complication or abnormality not defined in the NCI-CTCAE that is attributable to the therapy.

Capecitabine

Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle. Bevacizumab 10 mg/kg by vein on day 1 of a 21 day cycle.

Oxaliplatin 140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle. Capecitabine starting dose of 500 mg/m2 by mouth twice daily, on days 1 -14 of a 21 day cycle.

140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.

Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.

10 mg/kg by vein on day 1 of a 21 day cycle.

Apostolia M. Tsimberidou, MD, PHD

The goal of this clinical research study is to find the highest tolerable dose of the combination of oxaliplatin and capecitabine with or without bevacizumab that can be given to patients with advanced cancer that has spread to the liver. The safety of these drug combinations will also be studied.

The Study Drugs:

Oxaliplatin is designed to keep new cancer cells from growing.

Capecitabine is designed to interfere with the growth of cancer cells.

Bevacizumab is designed to block the growth of blood vessels that supply nutrients necessary for tumor growth. This may prevent or slow down the growth of cancer cells. Bevacizumab is no longer FDA approved to treat breast cancer.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a study "arm" based on the results of your screening tests. All patients will receive oxaliplatin and capecitabine. If your doctor thinks it is in your best interest, you will also receive bevacizumab.

* If you are in Arm 1, you will receive oxaliplatin, capecitabine, and bevacizumab.
* If you are in Arm 2, you will receive oxaliplatin and capecitabine.

Arm 1:

You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.

All participants will receive the same dose levels of oxaliplatin and bevacizumab.

Arm 2:

You will be assigned to a dose level of capecitabine based on when you joined this study. Up to 4 dose levels of capecitabine will be tested. Up to 6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of capecitabine is found.

All participants will receive the same dose levels of oxaliplatin.

Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.

In each arm, after the highest tolerable dose of the study drug combination is found, up to 20 extra participants with any tumor type will receive that dose level.

Additionally, after the highest tolerable dose is found for each arm, if a certain tumor type is found to have responded well to the study drug combination, 14 participants with that tumor type will receive the study drugs at that dose level.

Catheter Placement for Study Drug Administration:

You will be hospitalized to receive the study drug combination. On the day of your admission to the hospital, you will have a catheter (a sterile flexible tube that will be placed in the hepatic artery \[a blood vessel in the liver\] while you are under local anesthesia) through which you will receive the study drugs. The catheter will be placed and removed during each cycle. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.

You must lay in bed for the entire time that the catheter is in place. The catheter will either be removed right after your chemotherapy or it may remain in overnight.

Study Drug Administration:

Arm 1:

After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You will then receive bevacizumab by vein over 1½ hours. The first time you receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of the doses will be given over 30-60 minutes.

On Days 1-14 of each cycle, you will take capecitabine by mouth 2 times each day. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.

Arm 2:

On Day 1 of each 21-day cycle, you will receive oxaliplatin through the catheter over 2 hours.

After completion of oxaliplatin and bevacizumab, you will receive a total of 28 doses of capecitabine, 1 dose twice daily. You should take it with a cup (8 ounces) of non-carbonated water within 30 minutes after a meal.

Study Visits:

At each study visit, you will be asked about any other drugs you may be taking and about any side effects you may be having.

On Day 1 of each cycle:

* You will have a physical exam, including measurement of your weight and vital signs.
* Blood (about 4 teaspoons) will be drawn for routine tests.
* Blood (about 1 teaspoon) will be drawn to test your blood's ability to clot.
* If you are able to become pregnant, you will have a urine pregnancy test.

At the end of every even cycle (Cycles 2, 4, 6, and so on):

* Blood (about 1 tablespoon) will be drawn to test for tumor markers.
* You will have scans to check the status of the disease. This may include a chest x-ray, CT scan, MRI scan, a PET scan, and/or a PET/CT scan. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed.

Length of Study:

You may continue taking the study drug combination for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug combination if the disease gets worse or intolerable side effects occur.

If the disease is only in your liver and you have responded to treatment, you may be eligible to receive surgery. If eligible, you will receive surgery 6 weeks after taking your last dose of study drugs if you are in Arm 1 or 4 weeks after taking your last dose of study drugs if you are in Arm 2. The study doctor will discuss this with you in more detail and you will sign a separate consent form if you have surgery.

Your participation on the study will be over once you have completed the follow-up visit.

Follow-Up Visit:

About 6 weeks after your last dose of study drugs, the following tests and procedures will be performed:

* You will have a physical exam.
* Blood (about 3 teaspoons) will be drawn for routine tests.
* You will have a CT scan, MRI scan, PET scan, or PET/CT scan to check the status of the disease. If the study doctor thinks it is in your best interest, other types of scans may also be performed.

This is an investigational study. Oxaliplatin is FDA approved and commercially available for the treatment of colorectal cancer. Bevacizumab is FDA approved and commercially available for the treatment of colorectal and lung cancers. Capecitabine is FDA approved and commercially available for the treatment of colorectal and breast cancers.

Giving the study drugs together for advanced cancer is investigational.

Up to 116 participants will take part in this study. All will be enrolled at MD Anderson.

Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab

A Phase I Clinical Trial of Hepatic Arterial Infusion of Oxaliplatin, Oral Capecitabine, With or Without Systemic Bevacizumab for Patients With Advanced Cancer Metastatic to the Liver

If more than 33% of patients enrolled in any particular dose level develop dose limiting toxicity (DLT), treatment will continue at dose level immediately below. If not more than 33% of the patients in cohort develop DLT, this cohort considered MTD. DLT defined as any grade 3 or 4 non-hematologic toxicity as defined in current version of NCI CTCAE, even if related to study medications (except nausea and vomiting, electrolyte imbalances responsive to appropriate regimens or alopecia), any grade 4 nausea or vomiting \> 5 days despite maximum anti-nausea regimens, and any other grade 3 non-hematologic toxicity including symptoms/signs of vascular leak or cytokine release syndrome, but excluding alopecia; grade 4 thrombocytopenia; any grade 4 neutropenia of more than seven days duration, despite supportive care or associated with bleeding and/or sepsis; or any severe or life-threatening complication or abnormality not covered in NCI CTCAE. MTD defined by DLTs that occur in first cycle.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Hepatic Arterial Infusion (HAI) of Abraxane	NCT00732836	Liver Cancer Advanced Cancer... Solid Tumors	HAI Abraxane Hepatic Artery ... IV Abraxane	18 Years -	M.D. Anderson Cancer Center
A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis	NCT02102789	Metastatic Colo...	mFOLFOX6 HAI	18 Years - 70 Years	Sun Yat-sen University
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM	NCT03125161	Colorectal Aden...	HAI chemotherapy ± ...	18 Years - 75 Years	Fudan University
HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver	NCT00980239	Liver Cancer Advanced Cancer	Irinotecan Bevacizumab Oxaliplatin Cetuximab	-	M.D. Anderson Cancer Center
Study Comparing HAI Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM	NCT03125161	Colorectal Aden...	HAI chemotherapy ± ...	18 Years - 75 Years	Fudan University
A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis	NCT02102789	Metastatic Colo...	mFOLFOX6 HAI	18 Years - 70 Years	Sun Yat-sen University
Hepatic Arterial Infusion (HAI) of Abraxane	NCT00732836	Liver Cancer Advanced Cancer... Solid Tumors	HAI Abraxane Hepatic Artery ... IV Abraxane	18 Years -	M.D. Anderson Cancer Center
Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab	NCT01213238	Advanced Cancer...	Oxaliplatin Capecitabine Bevacizumab	18 Years -	M.D. Anderson Cancer Center
Hepatic Arterial Infusion Oxaliplatin, Capecitabine With or Without Bevacizumab	NCT01213238	Advanced Cancer...	Oxaliplatin Capecitabine Bevacizumab	18 Years -	M.D. Anderson Cancer Center
HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver	NCT00980239	Liver Cancer Advanced Cancer	Irinotecan Bevacizumab Oxaliplatin Cetuximab	-	M.D. Anderson Cancer Center
A Study of Systemic Chemotherapy With/Without HAI in Patients With Initially Unresectable Colorectal Liver Metastasis	NCT02102789	Metastatic Colo...	mFOLFOX6 HAI	18 Years - 70 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for hai

Every month we try and update this database with for hai cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hai

Every month we try and update this database with for hai cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hai cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.