Neoplasms

All Conditions

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Digestive System Diseases

Adenocarcinoma

Disease Progression

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

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Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

All Drugs and Chemicals

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Herbal and Botanical

Bevacizumab

Irinotecan

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Mitogens

Topoisomerase I Inhibitors

Enzyme Inhibitors

Tyrosine

Cola

Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1.

800 mg (4 x 200 mg tablets) self-administered orally at approximate same time each day on a continuous daily schedule Days 1-14 of 14 day cycle.

Brivanib

180 mg/m\^2 by vein on Day 1 of a 14 day cycle.

Michael Overman, MD

The goal of this clinical research study is to learn if adding brivanib to irinotecan can help control the disease in patients with colorectal cancer that has spread. The safety of this drug combination will also be studied.

Study Drugs:

Brivanib is designed to keep cancer cells from receiving the blood supply they need. This may slow down the growth of cancer cells.

Irinotecan is designed to interfere with the DNA (genetic material) of cancer cells. This may slow down the growth and spread of cancer cells.

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take brivanib by mouth 1 time every day. The study drug should be taken at the same time each day with a glass (about 8 ounces) of water. You can take it with or without food.

You will be given irinotecan by vein over about 1½ hours on Day 1 of each 14-day cycle. You may be given other drugs to help prevent side effects. The study staff will tell you about these drugs, how they will be given, and the possible risks.

If you have a side effect, you should tell your doctor or study nurse right away. Your study doctor may prescribe drugs for your side effects, delay future treatments, lower the dose of the study drugs, or stop your treatment with the study drugs.

Study Visits:

On Day 7 of Cycle 1:

* Your vital signs will be measured.
* Blood (about 2 tablespoons) will be drawn for routine tests and to check your thyroid function. If the doctor thinks it is needed, part of the blood may be used to check your blood's ability to clot.

Before all cycles, starting with Cycle 2:

* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* Blood (about 1-2 tablespoons) will be collected for routine tests. If the doctor thinks it is needed, part of the blood may be used to check your blood's ability to clot if needed.
* You will be asked about any drugs you may have taken and side effects you may have had.
* Before Cycles 2 and 3 only, blood (about 1 tablespoon) will be drawn to check your thyroid function.

Every 8 weeks:

* You will have a CT scan or MRI scan to check the status of the disease.
* Blood (about 2-3 tablespoons) will be drawn for thyroid, CEA, and cytokine testing.
* Urine will be collected for routine tests.

Every 12 weeks (Weeks 12, 24, 36, and so on), you will have an ECHO to check your heart function.

Length of Study:

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

End-of-Treatment Visit:

Within 2 weeks after you stop taking the study drugs, the following tests and procedures will be performed if not done in the last 14 days:

* You will be asked about any side effects you may have had and any drugs you may be taking.
* You will have a physical exam, including measurement of your vital signs.
* Your performance status will be recorded.
* You will have a CT scan or MRI scan to check the status of the disease.
* Blood (about 1-2 tablespoons) and urine will be collected for routine tests.
* Blood (about 2-3 tablespoons) will be drawn for thyroid, CEA, and cytokine testing.

Long-Term Follow-Up:

After you stop taking the study drugs, you will be called every 3 months. You will be asked questions about your health. These calls should last about 15 minutes each time.

This is an investigational study. Brivanib is not FDA approved or commercially available. It is currently being used for research purposes only. Irinotecan is FDA approved and commercially available for the treatment of colorectal cancer. The combination of brivanib and irinotecan is considered investigational.

Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.

Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF

Phase II Study of Second-line Irinotecan Plus Brivanib, a Dual Tyrosine Inhibitor of VEGFR and FGFR, in Metastatic Colorectal Cancer Patients Enriched for Elevated Levels of Plasma FGF Following Progression on Bevacizumab-based Treatment

Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Bristol-Myers Squibb

M.D. Anderson Cancer Center

One participant enrolled of the eight (8) was not treated, therefore seven (7) participants are reported as the at risk population.

Brivanib 800 mg orally daily Days 1-14, and Irinotecan intravenously 180 mg/m\^2 on Day 1. One cycle is 14 days.

Brivanib + Irinotecan

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Study was terminated early by sponsor with low accrual. Due to small number of participants, no statistical analysis was possible.

As a result of the drug sponsor closing study early, the accrual goal was not met and with the small number of participants enrolled no statistical analysis or conclusions was possible from the data.

Dr. Michael Overman, Associate Professor, GI Medical Oncology

Number of Participants With Median Progression-Free Survival (PFS)

Overall Study

Adenoma

Polyps

Hypoglycemic Agents

Metformin

Participants receive two tablets of Metformin ER 500 mg once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy. Dose will be reached in a gradual escalation scheme to improve gastrointestinal tolerance. If participants experience side effects during dose escalation regimen, they will be reduced to one tablet of 500 mg daily, and may continue taking 500 mg daily for the duration of the study.

Control group given matched Placebo once daily for no more than twelve to eighteen months allowing time for at least one follow up colonoscopy.

Starting dose: 500 mg by mouth daily for 1 week with weekly increases of 250 mg daily to target dose of 1000 mg daily.

Metformin ER

Placebo

William Ross, MD

The goal of this clinical research study is to learn if metformin extended release (ER) can prevent colonic adenomas from becoming cancerous. Metformin ER will be compared to a placebo.

Metformin ER is designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.

A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Colonic adenomas are considered pre-cancerous, but they may change into colorectal cancer. Patients have a higher risk of developing additional adenomas if adenomas are found at the time of their follow-up colonoscopy.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive metformin ER

If you are in Group 2, you will receive a placebo.

Neither you nor the study staff will know if you are receiving the study drug or the placebo. However, if needed for your safety, the study staff will be able to find out what you are receiving.

Study Drug Administration:

You will take metformin ER/placebo tablets by mouth 1 time a day with food for 12-18 months (usually 12 months but sometimes up to 18 if the doctor thinks it is needed). This will allow time for at least 1 repeat follow-up colonoscopy.

The dose of metformin ER will be increased at Week 2 and again at Week 3. If you have side effects, the dose may be lowered if the doctor thinks it is needed.

Study Visit:

At 3-12 months or 3-18 months after you start taking metformin ER/placebo, you will have another colonoscopy and standard tissue collection for colonic adenoma(s). This tissue will be used for biomarker testing. Blood (about 3 tablespoons) will be drawn for testing on your blood sugar and for biomarker testing. You will need to fast for 8 hours before this test.

Your blood and tissue will also be used for research on the cause of colorectal cancer and biomarker testing.

Length of Treatment:

You may continue taking the study drug for 12 months. However, if your doctor thinks it is needed, a follow-up colonoscopy may be scheduled for you at either 15 or 18 months after enrollment. If this is the case, you will continue taking the drug for up to 18 months. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.

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

This is an investigational study. Metformin ER is FDA approved and commercially available for the treatment of type 2 diabetes. Its use to prevent colonic adenomas is investigational.

Up to 128 patients will take part in this study. All will be enrolled at MD Anderson.

Prospective Trial of Metformin - Chemoprevention Role

A Prospective Placebo-control Double-blind Randomized Trial of Metformin in Chemoprevention of Metachronous Colonic Neoplastic Polyps

Primary endpoint defined as change in overall proliferation index between baseline and first return visit, that is, percentage of Ki-67-stained nuclei, in normal rectal mucosa. Tissue samples will be obtained at baseline colonoscopy and subsequent exams for analysis including Ki67, caspase 3, and various biomarkers and immunohistochemicals studies.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF	NCT01367275	Colorectal Canc... Colorectal Aden...	Brivanib Irinotecan	18 Years -	M.D. Anderson Cancer Center
Prospective Trial of Metformin - Chemoprevention Role	NCT01550900	Colorectum	Metformin ER Placebo	40 Years - 75 Years	M.D. Anderson Cancer Center
Irinotecan Plus Brivanib in Metastatic Colorectal Cancer (CRC) Enriched for Elevated Levels of Plasma FGF	NCT01367275	Colorectal Canc... Colorectal Aden...	Brivanib Irinotecan	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for colorectum

Every month we try and update this database with for colorectum 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 colorectum

Every month we try and update this database with for colorectum 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 colorectum 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.