Expired Study
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Detroit, Michigan 48201


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00016185


Primary Contact:

Study Chair
Philip A. Philip, MD, PhD, FRCP
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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