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Flavopiridol and Docetaxel in Treating Patients With Advanced Solid Tumors

Sponsor
Barbara Ann Karmanos Cancer Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00016185
Collaborator
National Cancer Institute (NCI) (NIH)
1
Location
57
Duration (Months)

Study Details

Study Description

Brief 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 and docetaxel in treating patients who have advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase I Study Of Flavopiridol And Docetaxel (Taxotere) In Patients With Advanced Cancers
Study Start Date :
Mar 1, 2001
Actual Primary Completion Date :
Feb 1, 2003
Actual Study Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379

    Sponsors and Collaborators

    • Barbara Ann Karmanos Cancer Institute
    • National Cancer Institute (NCI)

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00016185
    Other Study ID Numbers:
    • CDR0000068605
    • P30CA022453
    • WSU-C-2197
    • NCI-1610
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Apr 5, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Docetaxel
    Alvocidib

    Study Results

    No Results Posted as of Apr 5, 2013