UCN-01 and Fluorouracil in Treating Patients With Metastatic Pancreatic Cancer
Pancreatic Cancer
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, recurrent pancreatic cancer, stage IV pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the pancreas Progressive disease after gemcitabine-based chemotherapy for metastatic disease At least 1 unidimensionally measurable metastatic lesion At least 20 mm by conventional techniques OR At least 10 mm by spiral CT scan Primary disease site is not considered a measurable lesion No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 OR Karnofsky 70-100% Life expectancy More than 8 weeks Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal Creatinine normal OR Creatinine clearance at least 60 mL/min Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac tachyarrhythmia Pulmonary No symptomatic chronic obstructive pulmonary disease No pulmonary embolism within the past 6 months Other No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents used in this study No diabetes mellitus uncontrolled by insulin or oral hypoglycemic agents No uncontrolled concurrent illness No ongoing or active infection No psychiatric illness or social situation that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception before, during, and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 1 prior chemotherapy regimen for metastatic or recurrent disease No prior fluorouracil in the adjuvant or inoperable, locally advanced setting (except as a radiosensitizer) No other concurrent chemotherapy Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy and recovered No prior mediastinal irradiation No concurrent radiotherapy Surgery Not specified Other No prior UCN-01 or other cyclin-dependent kinase inhibitors No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial anticancer agents or therapies No concurrent anticonvulsant medications
Sites / Locations
- Memorial Sloan-Kettering Cancer Center