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Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00023894
Collaborator
National Cancer Institute (NCI) (NIH)
54
Locations
55.1
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.

PURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma.

  • Determine the nature and degree of toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date :
Jul 1, 2001
Actual Study Completion Date :
Feb 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Histologically confirmed primary endometrial carcinoma

    • Recurrent or persistent disease

    • Refractory to curative therapy or established treatment

    • Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single agent or combination therapy) for endometrial carcinoma

    • Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

    • At least 1 unidimensionally measurable lesion

    • At least 20 mm by conventional techniques OR

    • At least 10 mm by spiral CT scan

    • At least 1 target lesion outside previously irradiated field

    • Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol, defined as any active GOG phase III protocol for the same patient population

    PATIENT CHARACTERISTICS:
    Age:
    • Any age
    Performance status:
    • GOG 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Absolute neutrophil count at least 1,500/mm^3

    • Platelet count at least 100,000/mm^3

    Hepatic:

    • Bilirubin no greater than 1.5 times upper limit of normal (ULN)

    • SGOT no greater than 2.5 times ULN

    • Alkaline phosphatase no greater than 2.5 times ULN

    • PT/PTT normal

    Renal:
    • Creatinine no greater than 1.5 times ULN
    Cardiovascular:

    • No prior thromboembolic events or thrombophlebitis

    • No prior recent myocardial infarction

    • No prior angina

    • No prior cerebrovascular accident

    • No prior transient ischemic attacks

    Other:

    • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

    • No grade 2 or greater sensory or motor neuropathy

    • No active infection requiring antibiotics

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • At least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma
    Chemotherapy:

    • See Disease Characteristics

    • At least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered

    Endocrine therapy:

    • At least 1 week since prior hormonal therapy for endometrial carcinoma

    • Concurrent hormone replacement therapy allowed

    Radiotherapy:

    • See Disease Characteristics

    • At least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered

    Surgery:

    • At least 3 weeks since prior surgery for endometrial carcinoma and recovered

    • At least 6 months since prior re-vascularization procedures (e.g., coronary artery bypass graft, carotid endarterectomy or bypass, or angioplasty with or without stents)

    Other:

    • At least 3 weeks since other prior therapy for endometrial carcinoma

    • At least 6 months since prior thrombolytic procedures

    • No prior cyclin-dependent kinase inhibitors

    • No prior anticancer therapy that would preclude study

    • No concurrent amifostine or other protective reagents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    3 Community Hospital of Los Gatos Los Gatos California United States 95032
    4 Chao Family Comprehensive Cancer Center Orange California United States 92868
    5 University of Colorado Cancer Center Denver Colorado United States 80010
    6 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5001
    7 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    8 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612-3864
    9 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    10 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    11 Holden Comprehensive Cancer Center Iowa City Iowa United States 52242-1009
    12 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    13 Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda Maryland United States 20892-1182
    14 Tuft-New England Medical Center Boston Massachusetts United States 02111
    15 University of Massachusetts Memorial Medical Center - University Campus Worcester Massachusetts United States 01605-2982
    16 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    17 Mayo Clinic Cancer Center Rochester Minnesota United States 55905-0001
    18 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    19 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    20 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    21 Washington University School of Medicine Saint Louis Missouri United States 63110
    22 Cooper Hospital/University Medical Center Camden New Jersey United States 08103-1489
    23 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    24 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    25 North Shore University Hospital Manhasset New York United States 11030
    26 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    27 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11794-8091
    28 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    29 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    30 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1065
    31 Barrett Cancer Center Cincinnati Ohio United States 45267-0526
    32 Ireland Cancer Center Cleveland Ohio United States 44106
    33 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    34 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    35 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    36 Abington Memorial Hospital Abington Pennsylvania United States 19001-3788
    37 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    38 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    39 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    40 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    41 Medical University of South Carolina Charleston South Carolina United States 29425-2233
    42 Brookview Research, Inc. Nashville Tennessee United States 37203
    43 Simmons Cancer Center - Dallas Dallas Texas United States 75390-9032
    44 University of Texas Medical Branch Galveston Texas United States 77555-0587
    45 CCOP - M.D. Anderson Research Base Houston Texas United States 77030-4009
    46 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    47 Fletcher Allen Health Care - Medical Center Campus Burlington Vermont United States 05401
    48 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    49 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    50 Tacoma General Hospital Tacoma Washington United States 98405
    51 Australia New Zealand Gynaecological Oncology Trials Group Camperdown New South Wales Australia 1450
    52 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
    53 Norwegian Radium Hospital Oslo Norway N-0310
    54 University of Birmingham Birmingham England United Kingdom B15 2TT

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Edward C. Grendys, MD, Robert H. Lurie Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00023894
    Other Study ID Numbers:
    • CDR0000068874
    • GOG-0129M
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Jun 24, 2013
    Last Verified:
    May 1, 2004
    Keywords provided by , ,
    recurrent endometrial carcinoma
    Additional relevant MeSH terms:
    Endometrial Neoplasms
    Alvocidib

    Study Results

    No Results Posted as of Jun 24, 2013