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Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

Sponsor
Gynecologic Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00005837
Collaborator
National Cancer Institute (NCI) (NIH)
72
Locations
52
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 oxaliplatin in treating patients who have recurrent or refractory cervical cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: I. Determine the antitumor activity of oxaliplatin by measuring response rate in patients with recurrent or refractory squamous cell carcinoma of the cervix who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of this drug in this patient population.

OUTLINE: Patients receive oxaliplatin IV over 2 hours. Treatment continues every 21 days for a maximum of 9 courses in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 patients will be accrued for this study within 12-14 months.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Phase II Evaluation of Oxaliplatin in Persistent or Recurrent Squamous Cell Carcinoma of the Cervix
Study Start Date :
Feb 1, 2000
Actual Study Completion Date :
Jun 1, 2004

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 refractory or recurrent squamous cell carcinoma of the cervix that has failed local therapeutic measures and considered incurable Bidimensionally measurable disease Must not be eligible for a higher priority GOG protocol No known brain metastases

    PATIENT CHARACTERISTICS: Age: Not specified 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 upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline phosphatase no greater than 3 times ULN Renal: Creatinine normal Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Fertile patients must use effective contraception No evidence of preexisting peripheral sensory neuropathy greater than CTC grade 1, including residual neuropathy attributed to prior chemotherapy and other chronic conditions (e.g., diabetes, venous stasis, and carpal tunnel syndrome) No history of allergy to platinum compounds or to antiemetics appropriate for administration in conjunction with protocol directed chemotherapy No other uncontrolled concurrent illness (e.g., ongoing or active infection) No other malignancy within the past 5 years except nonmelanoma skin cancer and no other prior malignancy whose prior cancer treatment contraindicates this protocol therapy

    PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors (CSFs) during first course of therapy At least 24 hours since prior CSFs during subsequent courses of therapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No prior oxaliplatin No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Surgery: At least 3 weeks since prior surgery and recovered Other: At least 3 weeks since prior anticancer therapy and recovered No other concurrent investigational agents No concurrent antiretroviral therapy (HAART)

    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 USC/Norris Comprehensive Cancer Center Los Angeles California United States 90033-0800
    4 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90095-1781
    5 Chao Family Comprehensive Cancer Center Orange California United States 92868
    6 Women's Cancer Center Palo Alto California United States 94304
    7 University of Colorado Cancer Center Denver Colorado United States 80262
    8 Vincent T. Lombardi Cancer Research Center, Georgetown University Washington District of Columbia United States 20007
    9 Walter Reed Army Medical Center Washington District of Columbia United States 20307-5000
    10 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612
    11 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    12 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    13 MBCCOP - University of Illinois at Chicago Chicago Illinois United States 60612-7323
    14 Rush-Presbyterian-St. Luke's Medical Center Chicago Illinois United States 60612
    15 University of Chicago Cancer Research Center Chicago Illinois United States 60637
    16 CCOP - Central Illinois Decatur Illinois United States 62526
    17 CCOP - Evanston Evanston Illinois United States 60201
    18 Indiana University Cancer Center Indianapolis Indiana United States 46202-5265
    19 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309-1016
    20 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    21 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    22 Johns Hopkins Oncology Center Baltimore Maryland United States 21287
    23 Medicine Branch Bethesda Maryland United States 20892
    24 Radiation Oncology Branch Bethesda Maryland United States 20892
    25 Tufts University School of Medicine Boston Massachusetts United States 02111
    26 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    27 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    28 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
    29 University of Minnesota Cancer Center Minneapolis Minnesota United States 55455
    30 University of Mississippi Medical Center Jackson Mississippi United States 39216-4505
    31 Keesler Medical Center - Keesler AFB Keesler AFB Mississippi United States 39534-2576
    32 Ellis Fischel Cancer Center Columbia Missouri United States 65203
    33 CCOP - Kansas City Kansas City Missouri United States 64131
    34 Washington University School of Medicine Saint Louis Missouri United States 63110
    35 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    36 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    37 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68131
    38 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    39 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    40 Cancer Center of Albany Medical Center Albany New York United States 12208
    41 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    42 North Shore University Hospital Manhasset New York United States 11030
    43 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    44 University of Rochester Cancer Center Rochester New York United States 14642
    45 State University of New York Health Sciences Center - Stony Brook Stony Brook New York United States 11790-7775
    46 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    47 Duke Comprehensive Cancer Center Durham North Carolina United States 27710
    48 Comprehensive Cancer Center of Wake Forest University Baptist Medical Center Winston-Salem North Carolina United States 27157-1082
    49 Barrett Cancer Center, The University Hospital Cincinnati Ohio United States 45219
    50 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    51 Cleveland Clinic Cancer Center Cleveland Ohio United States 44195
    52 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210
    53 University of Oklahoma College of Medicine Oklahoma City Oklahoma United States 73190
    54 CCOP - Sooner State Tulsa Oklahoma United States 74136
    55 CCOP - Columbia River Program Portland Oregon United States 97213
    56 Abington Memorial Hospital Abington Pennsylvania United States 19001
    57 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033
    58 University of Pennsylvania Cancer Center Philadelphia Pennsylvania United States 19104
    59 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107
    60 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    61 CCOP - MainLine Health Wynnewood Pennsylvania United States 19096
    62 Medical University of South Carolina Charleston South Carolina United States 29425-0721
    63 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    64 CCOP - Baptist Cancer Institute Memphis Tennessee United States 38117
    65 Brookview Research, Inc. Nashville Tennessee United States 37203
    66 Simmons Cancer Center - Dallas Dallas Texas United States 75235-9154
    67 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030
    68 CCOP - Scott and White Hospital Temple Texas United States 76508
    69 Cancer Center, University of Virginia HSC Charlottesville Virginia United States 22908
    70 University of Washington Medical Center Seattle Washington United States 98195-6043
    71 Tacoma General Hospital Tacoma Washington United States 98405
    72 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2

    Sponsors and Collaborators

    • Gynecologic Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Paula M. Fracasso, MD, PhD, Washington University Siteman Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00005837
    Other Study ID Numbers:
    • CDR0000067852
    • GOG-127P
    First Posted:
    May 5, 2003
    Last Update Posted:
    Jun 21, 2013
    Last Verified:
    Jul 1, 2004
    Keywords provided by , ,
    recurrent cervical cancer
    cervical squamous cell carcinoma
    Additional relevant MeSH terms:
    Uterine Cervical Neoplasms
    Oxaliplatin

    Study Results

    No Results Posted as of Jun 21, 2013