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