Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Memorial Sloan Kettering Cancer Center

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

alvocidibDRUG

docetaxelDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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