Clinical Trial: Oxaliplatin in Treating Patients With Recurrent or Refractory Cervical Cancer

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Gynecologic Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

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 Treatment or Intervention Phase
recurrent cervical cancer
cervical squamous cell carcinoma
 Drug: oxaliplatin
Phase II

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapy;   Cervical Cancer;   Soft Tissue Sarcoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Oxaliplatin in Patients With Recurrent or Refractory Squamous Cell Carcinoma of the Cervix

Further Study Details: 

Study start: February 2000

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.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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)

--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

Location Information


Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States

Arizona
      CCOP - Greater Phoenix, Phoenix,  Arizona,  85006-2726,  United States

California
      Chao Family Comprehensive Cancer Center, Orange,  California,  92868,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

      USC/Norris Comprehensive Cancer Center, Los Angeles,  California,  90033-0800,  United States

      Women's Cancer Center, Palo Alto,  California,  94304,  United States

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80262,  United States

District of Columbia
      Vincent T. Lombardi Cancer Research Center, Georgetown University, Washington,  District of Columbia,  20007,  United States

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States

Hawaii
      MBCCOP - Hawaii, Honolulu,  Hawaii,  96813,  United States

Illinois
      CCOP - Central Illinois, Decatur,  Illinois,  62526,  United States

      CCOP - Evanston, Evanston,  Illinois,  60201,  United States

      MBCCOP - University of Illinois at Chicago, Chicago,  Illinois,  60612-7323,  United States

      Rush-Presbyterian-St. Luke's Medical Center, Chicago,  Illinois,  60612,  United States

      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States

Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States

Iowa
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States

      University of Iowa Hospitals and Clinics, Iowa City,  Iowa,  52242,  United States

Kentucky
      Albert B. Chandler Medical Center, University of Kentucky, Lexington,  Kentucky,  40536-0084,  United States

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21287,  United States

      Medicine Branch, Bethesda,  Maryland,  20892,  United States

      Radiation Oncology Branch, Bethesda,  Maryland,  20892,  United States

Massachusetts
      Tufts University School of Medicine, Boston,  Massachusetts,  02111,  United States

      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States

Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201,  United States

      CCOP - Ann Arbor Regional, Ann Arbor,  Michigan,  48106,  United States

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

Mississippi
      Keesler Medical Center - Keesler AFB, Keesler AFB,  Mississippi,  39534-2576,  United States

      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

Missouri
      CCOP - Cancer Research for the Ozarks, Springfield,  Missouri,  65807,  United States

      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

      Ellis Fischel Cancer Center, Columbia,  Missouri,  65203,  United States

      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States

Montana
      CCOP - Montana Cancer Consortium, Billings,  Montana,  59101,  United States

Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States

New Jersey
      Cooper Hospital/University Medical Center, Camden,  New Jersey,  08103,  United States

New York
      Cancer Center of Albany Medical Center, Albany,  New York,  12208,  United States

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      North Shore University Hospital, Manhasset,  New York,  11030,  United States

      State University of New York Health Science Center at Brooklyn, Brooklyn,  New York,  11203,  United States

      State University of New York Health Sciences Center - Stony Brook, Stony Brook,  New York,  11790-7775,  United States

      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States

North Carolina
      Comprehensive Cancer Center of Wake Forest University Baptist Medical Center, Winston Salem,  North Carolina,  27157-1082,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210,  United States

      Barrett Cancer Center, The University Hospital, Cincinnati,  Ohio,  45219,  United States

      Cleveland Clinic Cancer Center, Cleveland,  Ohio,  44195,  United States

      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States

Oklahoma
      CCOP - Sooner State, Tulsa,  Oklahoma,  74136,  United States

      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States

Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States

Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  United States

      CCOP - MainLine Health, Wynnewood,  Pennsylvania,  19096,  United States

      Fox Chase Cancer Center, Philadelphia,  Pennsylvania,  19111,  United States

      Kimmel Cancer Center of Thomas Jefferson University - Philadelphia, Philadelphia,  Pennsylvania,  19107,  United States

      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States

      University of Pennsylvania Cancer Center, Philadelphia,  Pennsylvania,  19104,  United States

South Carolina
      CCOP - Upstate Carolina, Spartanburg,  South Carolina,  29303,  United States

      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

Tennessee
      Brookview Research, Inc., Nashville,  Tennessee,  37203,  United States

      CCOP - Baptist Cancer Institute, Memphis,  Tennessee,  38117,  United States

Texas
      CCOP - Scott and White Hospital, Temple,  Texas,  76508,  United States

      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States

      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Virginia
      Cancer Center, University of Virginia HSC, Charlottesville,  Virginia,  22908,  United States

Washington
      Tacoma General Hospital, Tacoma,  Washington,  98405,  United States

      University of Washington Medical Center, Seattle,  Washington,  98195-6043,  United States

Canada, Alberta
      Tom Baker Cancer Center - Calgary, Calgary,  Alberta,  T2N 4N2,  Canada

Study chairs or principal investigators

Paula M. Fracasso,  Study Chair,  Gynecologic Oncology Group   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067852; GOG-127P
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005837
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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