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Combination Chemotherapy in Treating Patients With Advanced Solid Tumors

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00045448
Collaborator
(none)
1
Location
92
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 with docetaxel in treating patients who have advanced solid tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

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 Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Single Center Open-Label Non-Comparative Phase I Dose Finding Study Of Weekly Flavopiridol In Combination With Weekly Docetaxel In Patients With Advanced Solid Tumors
Study Start Date :
Apr 1, 2002
Actual Primary Completion Date :
Jan 1, 2006
Actual Study Completion Date :
Dec 1, 2009

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 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10021

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00045448
    Other Study ID Numbers:
    • AVENTIS-HMR1275A/1501
    • MSKCC-02034
    • NCI-G02-2106
    • CDR0000256563
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    May 30, 2013
    Last Verified:
    Dec 1, 2009
    Keywords provided by , ,
    unspecified adult solid tumor, protocol specific
    Additional relevant MeSH terms:
    Neoplasms
    Docetaxel
    Alvocidib

    Study Results

    No Results Posted as of May 30, 2013