Gemcitabine Plus Flavopiridol in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Phase I trial to study the effectiveness of gemcitabine plus flavopiridol in treating patients who have advanced solid tumors. Drugs used in chemotherapy 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

DISEASE CHARACTERISTICS:

• Histologically proven solid tumor for which gemcitabine is a treatment option or for which no effective therapy exists

• Previously untreated disease allowed

• No large and potentially symptomatic pericardial effusion or undrained pleural effusion (with or without pleurodesis)

• No CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm3

• Platelet count at least 100,000/mm3

• No prior thrombotic events

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• SGOT no greater than 2 times upper limit of normal

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No clinically significant cardiac disease

• No prior deep venous thrombus

• No prior arterial vascular event

• No prior myocardial infarction

• No unstable angina

• No prior transient ischemic attack or cerebrovascular accident

• No cardiac arrhythmias that could be related to cardiac ischemia

Pulmonary:

• No clinically significant pulmonary disease

• No history of pulmonary embolism

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No active infection

• No severe malnutrition or intractable emesis

• No chronic diarrheal disease within the past 6 months

PRIOR CONCURRENT THERAPY:

Chemotherapy:

• No more than 1 prior chemotherapy regimen

• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered

• Prior gemcitabine or flavopiridol allowed

• No other concurrent chemotherapy

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

• No prior radiotherapy to more than 50% of bone marrow

• No concurrent radiotherapy