Expired Study
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New York, New York 10021


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.

Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of flavopiridol when administered in combination with 2 different doses of docetaxel in patients with advanced solid tumors. - Determine the clinical pharmacokinetics of this regimen in these patients. - Determine, preliminarily, the therapeutic activity of this regimen in these patients. OUTLINE: This is a dose-escalation study of flavopiridol. Patients receive docetaxel IV over 30 minutes followed at least 4 hours later by flavopiridol IV over 1 hour on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity. Separate MTDs of flavopiridol are determined when flavopiridol is combined with 2 different doses of docetaxel. A total of 10 patients are treated at each flavopiridol MTD. Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 6-56 patients will be accrued for this study.


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



Primary Contact:

Study Chair
Gary K. Schwartz, MD
Memorial Sloan-Kettering Cancer Center

Backup Contact:


Location Contact:

New York, New York 10021
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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