Gemcitabine Hydrochloride and Alvocidib in Treating Patients With Solid Tumors

Inclusion Criteria

• •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