Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors

Barbara Ann Karmanos Cancer Institute

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 and docetaxel in treating patients who have advanced solid tumors.

OBJECTIVES: * Determine the dose-limiting toxic effects and maximum tolerated dose of flavopiridol and docetaxel in patients with advanced solid tumors. * Determine the objective response rate and duration of response in patients treated with this regimen. * Determine the pharmacokinetics of these drugs in this patient population. OUTLINE: This is a dose-escalation study. Patients receive docetaxel IV over 60 minutes on day 1 and flavopiridol IV continuously over 24 hours on day 2. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of docetaxel and flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study within 9-11 months.

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 or cytologically confirmed metastatic or unresectable solid tumor * No standard relatively effective curative or palliative measures exist * Measurable disease in at least 1 dimension * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * No known clinically active and uncontrolled brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 * Karnofsky 60-100% Life expectancy: * More than 12 weeks Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin normal * ALT/AST no greater than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine normal Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * No prior allergic reactions to compounds of similar chemical or biologic composition to flavopiridol or docetaxel * No other uncontrolled concurrent illness that would preclude study participation * No ongoing or active infection * No psychiatric illness or social situations that would preclude study compliance * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy Chemotherapy: * At least 6 months since prior taxane therapy * At least 4 weeks since other prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy except contraceptives, appetite stimulants, or replacement steroids Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery: * See Disease Characteristics Other: * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for HIV-positive patients

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Data from ClinicalTrials.gov

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