Neoplasms

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Rare Diseases

Adenocarcinoma

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Antineoplastic Agents

All Drugs and Chemicals

Gastrointestinal Agents

Gemcitabine

Pancrelipase

Pancreatin

Antimetabolites

Gemcitabine administered intravenously as a dose of 500 mg/m2 at a fixed dose rate of 10 mg/m2/min for the first 5 patients (to validate hematologic safety). Next 15 subsequent patients receive 750 mg/m2 at a fixed dose rate of 10 mg/m2/min. The drug infusion started 50-75 minutes prior to complete gross tumor removal (timing dependent on dose) in order to have drug administration complete at tumor removal.

500 mg/m2 at a fixed dose rate of 10 mg/m2/min by vein for the first 5 patients during pancreatic surgery. Next 15 subsequent patients receive 750 mg/m2 by vein at a fixed dose rate of 10 mg/m2/min.

Gauri Varadhachary, MD, MBBS

The goal of this clinical research study is to learn if gemcitabine given during surgery can enter pancreas cancer cells in patients who have already received chemotherapy and radiation.

Gemcitabine is a drug used to treat pancreatic cancer. However, it has not previously been studied if gemcitabine can enter pancreatic cancer cells. Gemcitabine is designed to block the growth of cancer cells, which may cause cancer cells to die.

Surgery:

If you agree to take part in this study, your surgery will be performed in the same way as it would be even if you were not taking part in this study. You will sign a separate consent form for surgery. The length of the surgery and the time you are under anesthesia will not be changed by taking part in the study.

During surgery, you will have routine procedures to learn if the disease has spread to other areas. If the disease has spread beyond the pancreas, surgical removal will not be possible.

If there are no signs of spread or other reasons the cancer cannot be removed, the surgeon will begin the process of removing the disease.

Study Drug Administration:

You will receive gemcitabine by vein during surgery. Gemcitabine will be given through an infusion catheter that is placed in your arm or chest in the operating room after you are asleep.

The infusion catheter is a standard-of-care procedure for all participants who are having this surgery. You will be asked to sign a separate consent form for the infusion catheter.

The infusion will take either 50 or 75 minutes, depending upon when you joined the study. The first 5 participants will receive gemcitabine over 50 minutes and the rest of the participants will receive gemcitabine over 75 minutes.

Blood and Tissue Collection:

Up to 8 blood samples (about 1 tablespoon each time) will be drawn over 70-95 minutes for pharmacokinetic (PK) testing on the day of surgery. PK testing measures the levels of study drug in your blood at different time points. The blood will also be used for biomarker testing. Biomarkers are chemical markers found in the blood and tissue that may be related to your reaction to the study drug.

Some of the tumor tissue and normal tissue removed during surgery will be collected to learn if gemcitabine is able to enter the tissue cells and for biomarker testing.

Length of Participation:

If for any reason during the surgery the surgeon decides that removal of the pancreas is not possible, you will not receive gemcitabine and your participation in this study will end.

Your active participation in this study will be over once you have had surgery and completed the follow-up.

Follow-Up:

One (1) time each day while you are in the hospital recovering from the surgery and then at the time of a routine clinic visit or by phone call at least 1 time a week, for up to 30 days after surgery, you will be asked if you have had any side effects.

This is an investigational study. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Its use during surgery is investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy

Tissue Pharmacokinetics of Intraoperative Gemcitabine in Adenocarcinoma of the Pancreas After Preoperative Chemoradiation Therapy

The quantification of serum, PBMC, and cancer tissue levels of gemcitabine from frozen samples will be assessed using standardized techniques in high performance liquid chromatography-mass spectometry (HPLC/MS).

Gemcitabine incorporation in DNA will be quantified by a proprietary LC/MS/MS method developed by Eli Lilly and performed by Advion BioServices. DNA extracted from the tissue samples to be sent to Advion.

The mRNA level is measured using real time PCR and protein expressed by IHC, Gene expression level will be correlated to the gemcitabine measurements. Additionally measure markers of proliferation and apoptosis by p21and ki67 IHC and fluorescent TUNEL analysis.

The mRNA and protein expression of SHH, Gli, and SMO will be measured by RT-PCR and IHC method, respectively.

Measure markers of of proliferation and apoptosis by p21 and ki67 IHC and fluorescent TUNEL analysis.

M.D. Anderson Cancer Center

Gemcitabine administered intravenously at dose of 500 - 750 mg/m2 at a fixed dose rate of 10mg/m2/min, 50-75 minutes prior to complete gross tumor removal.

Intraoperative Gemcitabine Administration

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Gauri R Varadhachary,Professor, GI Medical Oncology

Samples inadequate for testing to meet objective; early termination of protocol due to low accrual.

To Quantifiably Assess Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue After a Single Intraoperative Infusion in Patients.

To Measure Intra-DNA Gemcitabine (dFdC) Levels Using a Novel Assay Liquid Chromatography-mass Spectometry (LC/MS/MS).

Samples inadequate for testing to meet objective; early termination of protocol due to low accrual

To Assess and Validate Previously Described Markers That May be Predictive of Gemcitabine Sensitivity or Resistance.

To Measure the Impact of Microvessel Density and the Molecular Expression Level of the Hh Signaling Pathway on Gemcitabine Delivery and DNA Incorporation.

To Correlate Intratumoral Gemcitabine Levels and Its Tumoricidal Activity With Ki67 Index and Intratumoral Apoptosis.

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Capecitabine

Capecitabine - Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.

Routine administration of twice daily dosing for days 1-14 of a 21-day cycle.

Phuong Khanh Morrow, MD

The goal of this clinical research study is to find out how gene expression (as well as how often this expression occurs) in patients with breast cancer affects how Xeloda® (capecitabine) is cleared (passed through the urine) from the body. The safety of capecitabine will also be studied.

Capecitabine, PK Testing, and DNA Analysis:

Capecitabine is designed to interfere with the growth of cancer cells, which may cause the cells to die. It is cleared from the body by certain proteins (which are made from DNA--the gene material of cells). Some patients have changes in these proteins that increase or decrease the rate that capecitabine is cleared from the body.

Researchers will use pharmacokinetic (PK) testing and DNA analysis to learn how capecitabine is cleared from your body. PK testing measures the amount of drug in the body at different time points. Information learned in this study may help researchers decide the best doses of capecitabine for future patients with breast cancer.

Screening Visit:

Before you can start treatment on this study, you will have about 2 teaspoons of blood drawn for routine tests and to make sure that you are able to receive chemotherapy. This screening blood test will help the study doctor decide if you are eligible to take part in this study.

Capecitabine Treatment:

If you are found to be eligible to take part in this study, you will be given capecitabine by mouth on the day you choose to start this therapy. Your treating doctor will prescribe capecitabine at a dose that is appropriate to treat the cancer. You can choose the start date, excluding weekends, but will need to begin therapy in the morning of the day you choose. You will have treatment with capecitabine even if you do not participate on this study.

PK Testing and DNA Analysis:

You will have blood drawn (about 2 teaspoons each time) for PK testing and DNA analysis of capecitabine at certain times throughout this study.

* For PK testing, blood will be drawn before your first dose of capecitabine, at 30, 60, and 90 minutes after the first dose, and then at 2, 6, 8, and 10 hours after the first dose.
* For DNA analysis, blood will only be drawn before you receive the first dose of capecitabine.

If your dose changes, these PK blood tests may need to be repeated.

Length of Study:

You will remain on this study for up to 6 months, unless the disease gets worse, you experience any intolerable side effects, or you decide to stop treatment with capecitabine.

This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.

Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism

Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan

Relationship between genomic variation and capecitabine metabolism (measured by limited PK sampling)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy	NCT01938716	Pancreatic Canc...	Gemcitabine	18 Years -	M.D. Anderson Cancer Center
Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism	NCT00960544	Breast Cancer	Capecitabine	18 Years -	M.D. Anderson Cancer Center
Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism	NCT00960544	Breast Cancer	Capecitabine	18 Years -	M.D. Anderson Cancer Center
Gemcitabine Pharmacokinetics After Preoperative Chemoradiation Therapy	NCT01938716	Pancreatic Canc...	Gemcitabine	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pharmacokinetic testing