Gemcitabine Hydrochloride and Alvocidib in Treating Patients With Solid Tumors

You may be eligible if

• Negative pregnancy test
• Fertile patients must use effective contraception
• No active infection
• No severe malnutrition
• No more than 2 prior chemotherapy regimens:
• * Prior combined modality therapy (e.g., full-dose chemotherapy with radiosensitizing chemotherapy and radiotherapy) is considered 1 prior regimen if all therapy was delivered as part of 1 comprehensive treatment plan
• More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• No other concurrent chemotherapy
• At least 6 months since prior radiotherapy to the lung parenchyma or mediastinum and no evidence of radiation pneumonitis on chest CT scan
• At least 4 weeks since other prior radiotherapy and recovered
• No prior radiotherapy to more than 50% of marrow volume
• No concurrent radiotherapy
• Histologically confirmed solid tumor for which gemcitabine is a treatment option OR for which no efficacious therapy exists
• Must meet criteria for 1 of the following:
• * Measurable disease:
• * At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• * Nonmeasurable disease, including any of the following:
• * Small lesions (less than 20 mm by conventional techniques OR less than 10 mm by spiral CT scan)
• * Bone lesions
• * Cytologically positive pleural or peritoneal disease
• * Elevated tumor markers (e.g., carcinoembryonic antigen, CA 125, CA 19-9, or other tumor marker)
• * Multinodular or confluent nonmeasurable pulmonary, hepatic, adrenal, intra-abdominal, or skin metastases
• * No active CNS metastases
• * Previously treated CNS metastases must be stable with no symptoms for 4 weeks after completion of treatment AND patient must be off steroid therapy or on a stable dose for at least the past 2 weeks
• * No known leptomeningeal metastases
• Performance status:
• * ECOG 0-1
• Hematopoietic:
• * Absolute neutrophil count at least 1,500/mm3;
• * Platelet count at least 100,000/mm3
• Hepatic:
• * Bilirubin no greater than 1.5 mg/dL;
• * SGOT no greater than 2.5 times upper limit of normal
• Renal:
• * Creatinine no greater than 1.5 mg/dL OR
• * Creatinine clearance at least 50 mL/min
• Cardiovascular:
• * None of the following within the past 6 months:
• * Myocardial infarction;
• * Unstable angina;
• * Transient ischemic attack;
• * Cerebrovascular accident
• * No new cardiac arrhythmia possibly related to cardiac ischemia;
• * No large and potentially symptomatic pericardial effusion;
• * No cardiac disease that would preclude study participation
• Pulmonary:
• * No pulmonary embolism within the past 6 months;
• * No large and potentially symptomatic pleural effusion;
• * No pulmonary disease that would preclude study participation
• Gastrointestinal:
• * No intractable emesis;
• * No grade 2 or greater chronic diarrheal disease within the past 6 months
• Not pregnant or nursing