Clincosm LogoSign in Get a demo

Gemcitabine in Treating Patients With Persistent or Recurrent Cancer of the Cervix

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT00006224
Collaborator
National Cancer Institute (NCI) (NIH)
39
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 who have persistent or recurrent cancer of the cervix.

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

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of gemcitabine in patients with persistent or recurrent nonsquamous cell carcinoma of the cervix who failed higher priority treatment protocols.

  • Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Courses repeat every 4 weeks 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: Approximately 15-37 patients will be accrued for this study within 1 year.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Evaluation of Gemcitabine in Persistent or Recurrent Non-Squamous Cell Carcinoma of the Cervix
Study Start Date :
Sep 1, 2000
Actual Primary Completion Date :
Apr 1, 2005

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:

    • Diagnosis of persistent or recurrent nonsquamous cell carcinoma of the cervix that has failed local therapeutic measures and is considered incurable

    • Eligible subtypes:

    • Adenocarcinoma

    • Adenosquamous carcinoma

    • Undifferentiated carcinoma

    • Must have documented disease progression

    • Histologic confirmation of original primary tumor required

    • Bidimensionally measurable disease

    • Ineligible for higher priority GOG protocol

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • GOG 0-2
    Life expectancy:
    • Not specified
    Hematopoietic:

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

    • Granulocyte count at least 1,500/mm^3

    Hepatic:

    • Bilirubin no greater than 1.5 times normal

    • SGOT and alkaline phosphatase no greater than 3 times normal

    Renal:
    • Creatinine no greater than 1.5 mg/dL
    Other:

    • No significant infection

    • Not pregnant

    • Fertile patients must use effective contraception

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

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • No concurrent filgrastim (G-CSF)
    Chemotherapy:

    • No prior gemcitabine

    • At least 3 weeks since other prior chemotherapy for cervical cancer and recovered

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

    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • At least 3 weeks since prior radiotherapy for cervical cancer and recovered
    Surgery:
    • At least 3 weeks since prior surgery for cervical cancer and recovered
    Other:
    • No prior cancer treatment that would preclude study

    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 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 33612-9497
    7 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    8 University of Chicago Cancer Research Center Chicago Illinois United States 60637-1470
    9 Indiana University Cancer Center Indianapolis Indiana United States 46202-5289
    10 Holden Comprehensive Cancer Center at The University of Iowa Iowa City Iowa United States 52242-1009
    11 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    12 Tufts University School of Medicine Boston Massachusetts United States 02111
    13 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    14 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    15 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    16 Ellis Fischel Cancer Center Columbia Missouri United States 65203
    17 Washington University School of Medicine Saint Louis Missouri United States 63110
    18 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    19 Cancer Center of Albany Medical Center Albany New York United States 12208
    20 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    21 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    22 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    23 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    24 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45267-0502
    25 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    26 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    27 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    28 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    29 Abington Memorial Hospital Abington Pennsylvania United States 19001
    30 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    31 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104-4283
    32 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    33 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    34 Brookview Research, Inc. Nashville Tennessee United States 37203
    35 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    36 Fletcher Allen Health Care - Medical Center Campus Burlington Vermont United States 05401
    37 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    38 Tacoma General Hospital Tacoma Washington United States 98405
    39 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Russell J. Schilder, MD, Fox Chase Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00006224
    Other Study ID Numbers:
    • CDR0000068144
    • GOG-0128F
    First Posted:
    Nov 11, 2003
    Last Update Posted:
    Apr 11, 2013
    Last Verified:
    Jun 1, 2005
    Keywords provided by , ,
    recurrent cervical cancer
    cervical adenocarcinoma
    cervical adenosquamous cell carcinoma
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Gemcitabine

    Study Results

    No Results Posted as of Apr 11, 2013