3-AP and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed pancreatic cancer Unresectable or metastatic disease Measurable disease Outside prior radiation ports OR within prior radiation port if evidence of disease progression after radiotherapy No CNS metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL (transfusion allowed) Hepatic Bilirubin no greater than 2.0 mg/dL AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN in the presence of liver metastases) Chronic viral hepatitis allowed Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No myocardial infarction within the past 3 months No uncontrolled congestive heart failure No uncontrolled coronary artery disease No uncontrolled arrhythmias Pulmonary No dyspnea at rest No dependence on supplemental oxygen Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No other malignancy except any of the following: Carcinoma in situ of the cervix treated with cone biopsy or resection Nonmetastatic basal cell or squamous cell skin cancer Any stage I malignancy curatively resected more than 5 years ago No active infection No known or suspected glucose-6-phosphate dehydrogenase deficiency No other concurrent life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy Prior vaccines, antibodies, cytokines, or small molecule cell signaling inhibitors allowed Chemotherapy No prior cytotoxic chemotherapy for unresectable or metastatic pancreatic cancer Endocrine therapy Not specified Radiotherapy See Disease Characteristics More than 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery More than 3 weeks since prior surgery and recovered Other More than 3 weeks since prior noncytotoxic treatment regimens and objective evidence of progressive disease No other concurrent investigational drugs
Sites / Locations
- University of Chicago Cancer Research Center
- Indiana Oncology Hematology Consultants
- University of Minnesota Cancer Center
- Sarah Cannon Cancer Center at Centennial Medical Center
- Universitair Ziekenhuis Gent
- Christie Hospital N.H.S. Trust
- Royal Marsden NHS Foundation Trust - Surrey