Houston, Texas 77030


Purpose:

The goal of this clinical research study is to find the highest tolerable dose of Abraxane™ (nab-paclitaxel) that can be given in combination with capecitabine and radiation therapy to patients with pancreatic cancer. The safety of this drug and drug combination will also be studied.


Study summary:

Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a dose level of nab-paclitaxel based on when you join this study. Up to 3 dose levels of nab-paclitaxel will be tested. About 3-6 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 nab-paclitaxel is found. You will receive standard doses of radiation therapy and capecitabine. Study Drug Administration: You will receive nab-paclitaxel by vein over about 30 minutes 1 time each week for 5½ weeks (5 doses total). You will receive radiation therapy 1 time each day on Monday through Friday for 5½ weeks (28 doses) and capecitabine by mouth 2 times each day. You will receive a separate consent form that describes radiation therapy, capecitabine, their risks, and additional dosing instructions (for capecitabine). Study Visits: Each week that you have radiation therapy: - You will have a physical exam. - Blood (about 2 teaspoons) will be drawn for routine tests. - You will fill out the questionnaire. - If you are taking phenytoin, blood (about 1 teaspoon) will be drawn to check the amount of phenytoin in your blood. - If you are taking blood thinners, blood (about 1 teaspoon) will be drawn to check how well your blood clots. At one time during this study, leftover tumor tissue from a previous biopsy will be collected to test if there is a certain type of protein (SMAD4) in the tissue that may predict if the disease will come back. Depending on your SMAD4 status, the study doctor may be able to predict where in your body (either in the pancreas or in a different part of your body) the disease may come back. Length of Study: You may continue taking nab-paclitaxel, radiation therapy, and capecitabine for up to 5½ weeks. If the disease appears to get better after the end-of-treatment visit (described below) you may be able to continue taking nab-paclitaxel 1 time each week, unless the disease appears to get worse. You will no longer be able to take nab-paclitaxel if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on this study will be over after the end-of-treatment visit. End-Of-Treatment Visit: About 4-6 weeks after you finish radiation therapy, you will have an end-of-treatment visit. At this visit: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - If you are taking phenytoin, blood (about 1 teaspoon) will be drawn to check the amount of phenytoin in your blood. - If you are taking blood thinners, blood (about 1 teaspoon) will be drawn to check how well your blood clots. - You will have a CT scan of your chest and either an MRI or CT scan of your abdomen to check the status of the disease. - You will fill out the questionnaire. Follow-up Visits: You will have study visits every 3 months +/- 1 month. At each study visit: - You will have a physical exam. - Blood (about 2 tablespoons) will be drawn for routine tests. - You will have an MRI or CT scan of your abdomen and a chest CT to check the status of the disease. If the study doctor thinks that the tumor(s) can be removed, you will have surgery. You will be given a separate consent form that will describe the type of surgery you will have and its risks. This is an investigational study. Nab-paclitaxel and capecitabine are both FDA-approved and commercially available for the treatment of pancreatic cancer. Radiation therapy is delivered using FDA-approved and commercially available methods. It is considered investigational to give capecitabine and nab-paclitaxel together for pancreatic cancer. The study doctor can explain how the study drugs are designed to work. Up to 30 participants will take part in the study. All will be enrolled at MD Anderson.


Criteria:

Inclusion Criteria: 1. ECOG performance status of 0 or 1 2. Patients must be > 18 years of age. There will be no upper age restriction. 3. Cytologic or histologic proof of adenocarcinoma of the pancreas. Patients can have tumor which is locally advanced or borderline resectable. Unequivocal metastases and Islet cell tumors are not eligible. 4. All patients must be staged with a physical exam, CT of the chest and contrast-enhanced helical thin-cut abdominal CT. Unresectability is defined by CT criteria: a) evidence of tumor extension to the celiac axis or superior mesenteric (SM) artery, or b) evidence on either CT or angiogram of occlusion of the SM vein or SM/ portal vein confluence. 5. Patients must have received prior induction chemotherapy for at least 2 months and up to 8 months. At least three weeks should have elapsed after the last chemotherapy. 6. Patients must have adequate bone marrow function: Platelets >100,000 cells/mm3, Hemoglobin > 9.0g/dL and ANC >/= 1,500 cells/mm3. 7. Hepatic function: Bilirubin </= 1.5 mg/dL. Patients must have adequate liver function: AST and ALT < 2.5 X upper limit of normal, alkaline phosphatase < 2.5 X upper limit of normal. 8. Renal function: BUN < 30 mg/dL, creatinine </=1.5 mg/dL or creatinine clearance > 30ml/min (estimated as calculated with Cockcroft-Gault equation). 9. Patients must have signed informed consent indicating that they are aware of the investigational nature of the study, and are aware that participation is voluntary. 10. Patients must have < Grade 2 pre-existing peripheral neuropathy (per CTCAE) 11. Patients must have recovery from other clinically significant, non-hematologic toxicities to </= Grade 2. 12. Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment. 13. Negative serum or urine beta-hCG pregnancy test at screening for female patients of childbearing potential. Exclusion Criteria: 1. Prior abdominal radiotherapy 2. Current, recent (within 4 weeks of the first infusion of this study), or planned participation in any other experimental drug study. 3. Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a taxane therapy. 4. Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil. 5. Prior history of cancer within the last three years except for basal cell carcinoma of the skin or carcinoma in situ of the cervix. Patients with previous malignancies but without evidence of disease for 3 years will be allowed to enter the trial. 6. Pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Women / men of childbearing potential not using a reliable contraceptive method (oral contraceptive, other hormonal contraceptive, intrauterine device, diaphragm or condom). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). Patients must agree to continue contraception for 30 days from the date of the last study drug administration. 7. Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome or inability to swallow. 8. Known, existing uncontrolled coagulopathy, INR > 1.5. 9. Patients on Coumadin must be changed to Lovenox at least 1 week prior to starting capecitabine. Low dose (1 mg) Coumadin is allowed. Intravenous and low-molecular weight heparin are permitted. 10. Patients taking Sorivudine or Brivudine must be off of these drugs for 4 weeks prior to starting capecitabine. Patients taking cimetidine must have this drug discontinued. Ranitidine or a drug from another anti-ulcer class can be substituted for cimetidine if necessary. If patient is currently receiving allopurinol, must discuss with PI to see of another agent may substitute for it. 11. Inability to comply with study and/or follow-up procedures 12. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis or pulmonary hypersensitivity pneumonitis.


NCT ID:

NCT02394535


Primary Contact:

Principal Investigator
Sunil Krishnan, MD
M.D. Anderson Cancer Center

Sunil Krishnan, MD
Phone: 713-563-2300


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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