Gemcitabine Hydrochloride and Alvocidib in Treating Patients With Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase I trial is studying the side effects and best dose of gemcitabine hydrochloride and alvocidib in treating patients with solid tumors. Drugs used in chemotherapy, such as gemcitabine hydrochloride and alvocidib, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Gemcitabine

Criteria

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