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Docetaxel in Treating Patients With Recurrent or Persistent Endometrial Carcinoma (Cancer)

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00085332
Collaborator
National Cancer Institute (NCI) (NIH)
75
Locations

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with recurrent or persistent endometrial carcinoma (cancer).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

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

  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-18 months.

Study Design

Study Type:
Interventional
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Evaluation of Weekly Docetaxel (NSC #628503) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Dec 1, 2005

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 endometrial carcinoma

    • Recurrent or persistent disease

    • Refractory to curative or standard therapy

    • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

    • At least 1 target lesion

    • Tumors within a previously irradiated field are not considered target lesions

    • Received 1 prior chemotherapy regimen for endometrial carcinoma, including high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment

    • One additional non-cytotoxic regimen for recurrent or persistent disease allowed, including monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction

    • Ineligible for a higher priority GOG protocol

    PATIENT CHARACTERISTICS:

    Age

    • Any age

    Performance status

    • GOG 0-2

    Life expectancy

    • Not specified

    Hematopoietic

    • Absolute neutrophil count ≥ 1,500/mm^3

    • Platelet count ≥ 100,000/mm^3

    Hepatic

    • SGOT ≤ 2.5 times upper limit of normal (ULN)

    • Alkaline phosphatase ≤ 2.5 times ULN

    • Bilirubin ≤ 1.5 times ULN

    Renal

    • Creatinine ≤ 1.5 times ULN

    Other

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    • No neuropathy (sensory and motor) ≥ grade 2

    • No active infection requiring antibiotics

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

    PRIOR CONCURRENT THERAPY:

    Biologic therapy

    • See Disease Characteristics

    • At least 3 weeks since prior biologic or immunologic therapy for malignant tumor

    • No concurrent prophylactic growth factors

    • No concurrent prophylactic thrombopoietic agents

    Chemotherapy

    • See Disease Characteristics

    • Recovered from prior chemotherapy

    • No more than 1 prior cytotoxic chemotherapy regimen (single or combination cytotoxic drugs)

    Endocrine therapy

    • At least 1 week since prior hormonal therapy for malignant tumor

    • Concurrent hormone replacement therapy allowed

    Radiotherapy

    • See Disease Characteristics

    • Recovered from prior radiotherapy

    Surgery

    • Recovered from prior surgery

    Other

    • At least 3 weeks since other prior therapy for malignant tumor

    • No prior anticancer therapy that would preclude current protocol therapy

    • No concurrent amifostine or other protective reagents

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Comprehensive Cancer Center at University of Alabama at Birmingham Birmingham Alabama United States 35294-3300
    2 CCOP - Western Regional, Arizona Phoenix Arizona United States 85006-2726
    3 Jonsson Comprehensive Cancer Center at UCLA Los Angeles California United States 90095-1740
    4 Women's Cancer Center - Los Gatos Los Gatos California United States 95032
    5 Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center Orange California United States 92868
    6 University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver Colorado United States 80010
    7 Yale Comprehensive Cancer Center New Haven Connecticut United States 06520-8028
    8 CCOP - Christiana Care Health Services Newark Delaware United States 19713
    9 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5001
    10 H. Lee Moffitt Cancer Center and Research Institute at University of South Florida Tampa Florida United States 33612-9497
    11 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    12 Rush University Medical Center Chicago Illinois United States 60612-3824
    13 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612
    14 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    15 CCOP - Central Illinois Decatur Illinois United States 62794-9640
    16 CCOP - Evanston Evanston Illinois United States 60201
    17 CCOP - Carle Cancer Center Urbana Illinois United States 61801
    18 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    19 Saint Joseph Regional Medical Center South Bend Indiana United States 46617
    20 Holden Comprehensive Cancer Center at University of Iowa Iowa City Iowa United States 52242-1002
    21 Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington Kentucky United States 40536-0084
    22 Cancer Center at Tufts - New England Medical Center Boston Massachusetts United States 02111
    23 UMASS Memorial Cancer Center - University Campus Worcester Massachusetts United States 01605-2982
    24 CCOP - Michigan Cancer Research Consortium Ann Arbor Michigan United States 48106
    25 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
    26 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    27 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    28 Mayo Clinic Cancer Center Rochester Minnesota United States 55905-0001
    29 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    30 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    31 Keesler Medical Center - Keesler Air Force Base Keesler AFB Mississippi United States 39534-2576
    32 Ellis Fischel Cancer Center at University of Missouri - Columbia Columbia Missouri United States 65203
    33 CCOP - Kansas City Kansas City Missouri United States 64131
    34 Siteman Cancer Center at Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    35 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    36 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    37 Cancer Institute of New Jersey at the Cooper University Hospital Camden New Jersey United States 08103-1489
    38 SUNY Downstate Medical Center Brooklyn New York United States 11203
    39 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    40 North Shore University Hospital Manhasset New York United States 11030
    41 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    42 Long Island Cancer Center at Stony Brook University Hospital Stony Brook New York United States 11790-7775
    43 Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Chapel Hill North Carolina United States 27599-7570
    44 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    45 Gynecologic Oncology Network Greenville North Carolina United States 27858
    46 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1065
    47 Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio United States 45267-0520
    48 Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland Ohio United States 44106
    49 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44124
    50 Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Columbus Ohio United States 43210-1240
    51 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73104
    52 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
    53 Abington Memorial Hospital Abington Pennsylvania United States 19001-3788
    54 CCOP - Geisinger Clinic and Medical Center Danville Pennsylvania United States 17822-2001
    55 Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    56 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283
    57 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107
    58 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    59 UPMC Cancer Center at Magee-Womens Hospital Pittsburgh Pennsylvania United States 15213-3180
    60 Southeast Gynecologic Oncology Associates Knoxville Tennessee United States 37917
    61 Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville Tennessee United States 37232-2516
    62 Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas United States 75390-9032
    63 University of Texas Medical Branch Galveston Texas United States 77555-0587
    64 MD Anderson Cancer Center at University of Texas Houston Texas United States 77030-4009
    65 CCOP - Scott and White Hospital Temple Texas United States 76508
    66 Fletcher Allen Health Care - Medical Center Hospital of Vermont Campus Burlington Vermont United States 05401
    67 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    68 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109-1024
    69 MultiCare Regional Cancer Center at Tacoma General Hospital Tacoma Washington United States 98405
    70 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792-6188
    71 CCOP - Marshfield Clinic Research Foundation Marshfield Wisconsin United States 54449
    72 Australia New Zealand Gynaecological Oncology Trials Group Camperdown New South Wales Australia 1450
    73 Tom Baker Cancer Centre - Calgary Calgary Alberta Canada T2N 4N2
    74 Kagoshima City Hospital Kagoshima City Japan 892-8580
    75 Norwegian Radium Hospital Oslo Norway N-0310

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Agustin Garcia, MD, Premiere Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gynecologic Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00085332
    Other Study ID Numbers:
    • GOG-0129N
    • CDR0000368634
    First Posted:
    Jun 11, 2004
    Last Update Posted:
    Jan 13, 2014
    Last Verified:
    Jan 1, 2014
    Keywords provided by Gynecologic Oncology Group
    recurrent endometrial carcinoma
    stage III endometrial carcinoma
    stage IV endometrial carcinoma
    Additional relevant MeSH terms:
    Carcinoma
    Endometrial Neoplasms
    Docetaxel

    Study Results

    No Results Posted as of Jan 13, 2014