ADH-1, Gemcitabine Hydrochloride & Cisplatin in Treating Metastatic Pancreatic or Biliary Tract Cancer

Inclusion Criteria:

• Patients must have adenocarcinoma of the pancreas or biliary tree (intrahepatic orextrahepatic cholangiocarcinoma, gallbladder or ampulla of Vater) that is locallyadvanced, but non-resectable, metastatic or residual disease after attempted surgicalresection
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 or better
• Absolute neutrophil count (ANC) of 2000 per mcL or higher
• Platelet count of 100,000 per mcL or higher
• Patients must have a serum creatinine that is at or below the upper limits of theinstitutional normal range OR a creatinine clearance of 60 mL per min or highercorrected for body surface area (BSA)
• The total bilirubin must be at or below 2.0 mg/dL in the absence of biliaryobstruction; if the patient has biliary obstruction, biliary decompression will berequired; either endoscopic placement of a biliary stent or percutaneous transhepaticdrainage is acceptable; once biliary drainage has been established, institution ofprotocol therapy may proceed when the total bilirubin falls to 3.0 mg/dL or lower
• Patients need not have measurable disease for this study
• The patient must be aware of the neoplastic nature of his/her disease and willinglyprovide written, informed consent after being informed of the procedure to befollowed, the experimental nature of the therapy, alternatives, potential benefits,side-effects, risks, and discomforts
• Women of reproductive potential must be non-pregnant and non-nursing and must agree toemploy an effective barrier method of birth control throughout the study and for up to 6 months following treatment
• Women of child-bearing potential must have a negative pregnancy test within 7 days ofinitiating study; (no childbearing potential is defined as age 55 years or older andno menses for two years or any age with surgical removal of the uterus and/or bothovaries)

Exclusion Criteria:

• Patients may not have received prior chemotherapy for metastatic adenocarcinoma of thepancreas or biliary tract; prior adjuvant chemotherapy is acceptable provided that 6months or longer has elapsed since completion of the prior therapy
• History of allergy to platinum compounds or to antiemetics appropriate foradministration in conjunction with protocol-directed chemotherapy
• Uncontrolled inter-current illness including, but not limited to ongoing or activeinfection requiring intravenous antibiotics, symptomatic congestive heart failure,unstable angina pectoris, or serious, uncontrolled cardiac arrhythmia, that mightjeopardize the ability of the patient to receive the chemotherapy program outlined inthis protocol with reasonable safety
• Pregnant and nursing women are excluded from this study
• Patients with prior malignancy will be excluded except for adequately treated basalcell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or othercancers from which the patient has been disease-free for at least 5 years