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Gemcitabine in Treating Patients With Recurrent or Refractory Cancer of the Uterus

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00003316
Collaborator
National Cancer Institute (NCI) (NIH)
40
Locations

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 gemcitabine in treating patients with recurrent or refractory cancer of the uterus.

Condition or Disease Intervention/Treatment Phase
  • Drug: gemcitabine hydrochloride
 Phase 2

Detailed Description

OBJECTIVES: I. Determine the antitumor activity of gemcitabine in patients with recurrent or persistent leiomyosarcoma of the uterus who failed higher priority treatment protocols. II. Determine the toxicity of gemcitabine in these patients.

OUTLINE: Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks in the absence of unacceptable toxicity and disease progression. Patients with partial response, complete response, or stable disease receive at least 3 courses of therapy. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Evaluation of Gemcitabine in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
Study Start Date :
Aug 1, 1998
Actual Primary Completion Date :
Apr 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

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

    DISEASE CHARACTERISTICS: Histologically confirmed recurrent or persistent uterine leiomyosarcoma that is refractory to curative therapy or standard treatments Failed local therapeutic measures and considered incurable Measurable disease Not eligible for a higher priority GOG protocol

    PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater than 3 times normal Alkaline phosphatase no greater than 3 times normal Renal: Creatinine no greater than 1.5 mg/dL Other: No significant infection At least 5 years since any other invasive malignancy except nonmelanoma skin cancer

    PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior gemcitabine No more than 1 prior chemotherapy regimen (single agent or combination therapy) Endocrine therapy: At least 3 weeks since prior endocrine therapy Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama Comprehensive Cancer Center Birmingham Alabama United States 35294
    2 CCOP - Greater Phoenix Phoenix Arizona United States 85006-2726
    3 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    4 Chao Family Comprehensive Cancer Center Orange California United States 92868
    5 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    6 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    7 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    8 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    9 Indiana University Cancer Center Indianapolis Indiana United States 46202-5265
    10 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    11 Radiation Oncology Branch Bethesda Maryland United States 20892
    12 Tufts University School of Medicine Boston Massachusetts United States 02111
    13 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    14 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    15 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    16 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    17 CCOP - Kansas City Kansas City Missouri United States 64131
    18 Washington University School of Medicine Saint Louis Missouri United States 63110
    19 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    20 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    21 Cancer Center of Albany Medical Center Albany New York United States 12208
    22 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    23 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    24 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    25 Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157-1082
    26 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    27 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    28 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    29 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210
    30 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    31 Abington Memorial Hospital Abington Pennsylvania United States 19001
    32 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    33 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104
    34 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107
    35 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    36 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    37 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    38 University of Washington Medical Center Seattle Washington United States 98195-6043
    39 Tacoma General Hospital Tacoma Washington United States 98405
    40 NCIC-Clinical Trials Group Kingston Ontario Canada K7L 3N6

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Katherine Y. Look, MD, Indiana University Melvin and Bren Simon Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00003316
    Other Study ID Numbers:
    • CDR0000066265
    • GOG-131E
    First Posted:
    Apr 9, 2004
    Last Update Posted:
    Apr 11, 2013
    Last Verified:
    May 1, 2004
    Keywords provided by , ,
    recurrent uterine sarcoma
    uterine leiomyosarcoma
    Additional relevant MeSH terms:
    Sarcoma
    Gemcitabine

    Study Results

    No Results Posted as of Apr 11, 2013