Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: 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.

PURPOSE: Phase I trial to study the effectiveness of combining flavopiridol with docetaxel in treating patients who have advanced solid tumors.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Alvocidib; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced solid tumor that is refractory to standard therapy or for which no standard therapy exists

• Measurable or evaluable disease

• No symptomatic or untreated CNS metastases or primary CNS neoplasm

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,500/mm3

• Absolute neutrophil count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Hemoglobin at least 8 g/dL

Hepatic

• Bilirubin no greater than upper limit of normal (ULN)

• SGOT/SGPT no greater than 2.5 times ULN if alkaline phosphatase no greater than ULN OR

• Alkaline phosphatase no greater than 2.5 times ULN if SGOT/SGPT no greater than ULN

Renal

• Creatinine no greater than 1.5 mg/dL

Cardiovascular

• No history of cardiac arrhythmias

• No congestive heart failure

• No myocardial infarction within the past 6 months

Other

• No concurrent serious or uncontrolled infection

• No diabetes not adequately controlled with medication

• No peripheral neuropathy greater than grade 1

• No known allergy to docetaxel or other medications formulated in Polysorbate 80

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 2 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 4 weeks since prior immunotherapy

Chemotherapy

• At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)

• Prior taxanes allowed

• No prior flavopiridol

Endocrine therapy

• At least 4 weeks since prior hormonal therapy

Radiotherapy

• At least 4 weeks since prior radiotherapy

Surgery

• Not specified

Other

• Recovered from prior therapy

• No prior enrollment in this study