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PANCREATIC
Chemotherapy for Advanced Pancreatic Cancer
NCI 5624: A phase-II trial of sequential paclitaxel (Taxol) and bryostatin-1 for patients with advanced pancreatic cancer.
Consortium study: Montefiore (open), Mt. Sinai (distributed), NYU (distributed), North Shore (open), Weill Cornell (open)
Sponsor: National Cancer Institute
High-Dose Fluorouracil with PN401 Versus Gemcitabine
This phase-III, randomized, open-label trial compares two chemotherapeutic regimens for advanced pancreatic cancer: high-dose fluorouracil (5-FU) administered with PN401 versus the current standard therapy of gemcitabine. PN401 is an agent that permits the dosage of 5-FU to be increased safely to almost triple the standard dose, thereby enhancing its ability to kill cancer cells. In this study, one group of patients receives high-dose infusions of 5-FU combined with PN401, while the second group receives standard infusions of gemcitabine. Patients will be evaluated weekly for the first twelve weeks, then monthly for 9 months, and, finally, every three months for the next year.
Sponsor: Pro-Neuron, Inc.
Principal investigator: Dr. Roger Keresztes
0601-758
Radiotherapy Plus Chemotherapy
CALGB 80003: Phase-II trial of a regimen that combines gemcitabine, fluorouracil (5-FU) and radiation therapy for locally advanced non-metastatic pancreatic adenocarcinoma. Previous studies have suggested that treatment with radiation therapy and chemotherapy may provide considerable benefit to patients with localized pancreatic cancer when the cancer is not surgically removable. All patients enrolled in this trial receive the same two chemotherapy drugs plus radiation therapy.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal investigator: Dr. Scott Wadler
0702-365
Chemotherapies for Metastatic Pancreatic Cancer
CALGB 89904: A randomized, phase-II trial for patients with metastatic pancreatic cancer for the purpose of evaluating the safety and efficacy of four chemotherapeutic regimens: 1) gemcitabine and cisplatin; 2) gemcitabine alone; 3) gemcitabine and docetaxel (Taxotere); and 4) gemcitabine and irinotecan.
Sponsor: Cancer and Leukemia Group B (CALGB)
Principal investigator: Dr. Scott Wadler
0802-402
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