UCN-01 and Gemcitabine in Treating Patients With Unresectable or Metastatic Pancreatic Cancer

Inclusion Criteria: Histologically or cytologically confirmed unresectable or metastatic adenocarcinoma of the pancreas Unidimensionally measurable disease At least 20 mm by conventional techniques At least 10 mm by spiral CT scan Tumor lesions in a previously irradiated area are not considered measurable No known brain metastases Patients with signs or symptoms of CNS metastasis at any time during screening must have a negative CT scan or MRI of the brain Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 3 months WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count greater than 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL ALT and AST no greater than 2.5 times upper limit of normal Creatinine normal Creatinine clearance at least 60 mL/min No prior coronary artery disease No symptomatic cardiac dysfunction No prior myocardial infarction No active angina (even if controlled by medication) No positive stress test No uncontrolled arrhythmia Left ventricular ejection fraction at least 45% Patients with symptoms suggestive of coronary artery disease or arrhythmia must have no evidence of cardiac pathology No symptomatic pulmonary dysfunction Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No prior allergic reactions attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents No insulin-dependent diabetes mellitus No other concurrent uncontrolled illness No ongoing or active infections No concurrent psychiatric illness No other active malignancy No other solid tumor within the past 5 years except neoplasia in situ or nonmelanomatous skin cancer No social situations that would preclude study compliance No concurrent over-the-counter biologics No concurrent growth factors during the first study course At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered No more than 2 prior chemotherapy regimens (e.g., gemcitabine and/or experimental agents) alone or in combination with radiotherapy as neoadjuvant or adjuvant therapy for resectable, unresectable, or metastatic disease See Chemotherapy At least 6 weeks since prior radiotherapy and recovered Prior radiotherapy directed only at the primary tumor bed allowed No prior radiotherapy to the mediastinum, pelvis, lower spine, or more than 20% of bone marrow At least 4 weeks since prior major surgery At least 4 weeks since prior investigational agents Concurrent enrollment in non-therapy trials (e.g., quality of life) allowed No concurrent herbal remedies No concurrent treatment for another active malignancy No concurrent warfarin for anticoagulation No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial anticancer agents or therapies