Clinical Trial: Tirapazamine Plus Cisplatin in Treating Patients With Metastatic, Recurrent, or Refractory Cervical Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Southwest 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. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of tirapazamine plus cisplatin in treating patients who have metastatic, recurrent, or refractory cervical cancer.

Condition Treatment or Intervention Phase
recurrent cervical cancer
cervical squamous cell carcinoma
stage IV cervical cancer
cervical adenosquamous cell carcinoma
 Drug: cisplatin
 Drug: tirapazamine
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 Tirapazamine Plus Cisplatin for the Treatment of Metastatic, Recurrent, or Refractory Cervical Cancer

Further Study Details: 

Study start: August 1998

OBJECTIVES: I. Evaluate the survival of patients with metastatic or recurrent epithelial squamous or adenosquamous carcinoma of the cervix when treated with intravenous tirapazamine plus intravenous cisplatin.

II. Evaluate the unconfirmed complete and partial response rates of these patients, as well as, the nature and degree of toxicity associated with this regimen in this patient population.

PROTOCOL OUTLINE: Patients receive tirapazamine intravenously over 2 hours and then, following a 1 hour rest, receive cisplatin intravenously over 1 hour. Courses are repeated every 21 days. Treatment continues for 6-10 courses in the absence of unacceptable toxic effects or disease progression.

All patients are followed every 6 months for 2 years, then annually thereafter until death.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: No concurrent colony stimulating factor therapy
  • Chemotherapy: Prior chemotherapy (hydroxyurea, fluorouracil, metronidazole, cisplatin, or other platinum agent) allowed as a radiosensitizing agent only; No other concurrent chemotherapy
  • Endocrine therapy: Not specified
  • Radiotherapy: See Disease Characteristics; Prior radiotherapy allowed to less than 30% of the bone marrow only; Recovered from toxic effects; No concurrent radiotherapy
  • Surgery: See Disease Characteristics; Prior surgery allowed; Recovered from effects of prior surgery
  • Other: No prior systemic therapy for this disease

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: SWOG 0-2
  • Life expectancy: Not specified
  • Hematopoietic: WBC at least 3,000/mm3; Platelet count at least 100,000/mm3
  • Hepatic: Not specified
  • Renal: Creatinine no greater than 1.5 times upper limit of normal
  • Other: No history of allergic reaction to mannitol; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; No other prior malignancy except: Adequately treated basal cell or squamous cell skin cancer; In situ cervical cancer;Adequately treated stage I or II cancer from which the patient is currently in complete remission;Any other cancer from which the patient has been disease free for 5 years

Location Information


Alabama
      MBCCOP - University of South Alabama, Mobile,  Alabama,  36688,  United States

Arizona
      Arizona Cancer Center, Tucson,  Arizona,  85724,  United States

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

      Veterans Affairs Medical Center - Phoenix (Hayden), Phoenix,  Arizona,  85012,  United States

      Veterans Affairs Medical Center - Tucson, Tucson,  Arizona,  85723,  United States

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

      Veterans Affairs Medical Center - Little Rock (McClellan), Little Rock,  Arkansas,  72205,  United States

California
      Beckman Research Institute, City of Hope, Los Angeles,  California,  91010,  United States

      CCOP - Bay Area Tumor Institute, Oakland,  California,  94609-3305,  United States

      CCOP - Santa Rosa Memorial Hospital, Santa Rosa,  California,  95403,  United States

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

      David Grant Medical Center, Travis Air Force Base,  California,  94535,  United States

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

      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94115-0128,  United States

      University of California Davis Medical Center, Sacramento,  California,  95817,  United States

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

      Veterans Affairs Medical Center - Long Beach, Long Beach,  California,  90822,  United States

      Veterans Affairs Outpatient Clinic - Martinez, Martinez,  California,  94553,  United States

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

      Veterans Affairs Medical Center - Denver, Denver,  Colorado,  80220,  United States

Georgia
      CCOP - Atlanta Regional, Atlanta,  Georgia,  30342-1701,  United States

      Dwight David Eisenhower Army Medical Center, Fort Gordon,  Georgia,  30905-5650,  United States

Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States

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

      Loyola University Medical Center, Maywood,  Illinois,  60153,  United States

      Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital), Hines,  Illinois,  60141,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States

      Veterans Affairs Medical Center - Wichita, Wichita,  Kansas,  67218,  United States

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

      Veterans Affairs Medical Center - Lexington, Lexington,  Kentucky,  40511-1093,  United States

Louisiana
      Louisiana State University Health Sciences Center - Shreveport, Shreveport,  Louisiana,  71130-3932,  United States

      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States

      Tulane University School of Medicine, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - New Orleans, New Orleans,  Louisiana,  70112,  United States

      Veterans Affairs Medical Center - Shreveport, Shreveport,  Louisiana,  71130,  United States

Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States

      Veterans Affairs Medical Center - Boston (Jamaica Plain), Jamaica Plain,  Massachusetts,  02130,  United States

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

      CCOP - Grand Rapids Clinical Oncology Program, Grand Rapids,  Michigan,  49503,  United States

      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States

      Providence Hospital - Southfield, Southfield,  Michigan,  48075-9975,  United States

      University of Michigan Comprehensive Cancer Center, Ann Arbor,  Michigan,  48109-0752,  United States

      Veterans Affairs Medical Center - Ann Arbor, Ann Arbor,  Michigan,  48105,  United States

      Veterans Affairs Medical Center - Detroit, Detroit,  Michigan,  48201-1932,  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

      Veterans Affairs Medical Center - Biloxi, Biloxi,  Mississippi,  39531-2410,  United States

      Veterans Affairs Medical Center - Jackson, Jackson,  Mississippi,  39216,  United States

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

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

      CCOP - St. Louis-Cape Girardeau, Saint Louis,  Missouri,  63141,  United States

      St. Louis University Health Sciences Center, Saint Louis,  Missouri,  63110-0250,  United States

      Veterans Affairs Medical Center - Kansas City, Kansas City,  Missouri,  64128,  United States

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

New Mexico
      MBCCOP - University of New Mexico HSC, Albuquerque,  New Mexico,  87131,  United States

      Veterans Affairs Medical Center - Albuquerque, Albuquerque,  New Mexico,  87108-5138,  United States

New York
      Herbert Irving Comprehensive Cancer Center, New York,  New York,  10032,  United States

      Veterans Affairs Medical Center - Brooklyn, Brooklyn,  New York,  11209,  United States

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

      CCOP - Columbus, Columbus,  Ohio,  43206,  United States

      CCOP - Dayton, Kettering,  Ohio,  45429,  United States

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

      Veterans Affairs Medical Center - Cincinnati, Cincinnati,  Ohio,  45220-2288,  United States

      Veterans Affairs Medical Center - Dayton, Dayton,  Ohio,  45428,  United States

Oklahoma
      Oklahoma Medical Research Foundation, Oklahoma City,  Oklahoma,  73104,  United States

      Veterans Affairs Medical Center - Oklahoma City, Oklahoma City,  Oklahoma,  73104,  United States

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

      Oregon Cancer Center at Oregon Health Sciences University, Portland,  Oregon,  97201-3098,  United States

      Veterans Affairs Medical Center - Portland, Portland,  Oregon,  97207,  United States

South Carolina
      CCOP - Greenville, Greenville,  South Carolina,  29615,  United States

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

Texas
      Brooke Army Medical Center, Fort Sam Houston,  Texas,  78234,  United States

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

      Texas Tech University Health Science Center, Lubbock,  Texas,  79423,  United States

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States

      University of Texas Medical Branch, Galveston,  Texas,  77555-1329,  United States

      Veterans Affairs Medical Center - San Antonio (Murphy), San Antonio,  Texas,  78284,  United States

      Veterans Affairs Medical Center - Temple, Temple,  Texas,  76504,  United States

Utah
      Huntsman Cancer Institute, Salt Lake City,  Utah,  84132,  United States

      Veterans Affairs Medical Center - Salt Lake City, Salt Lake City,  Utah,  84148,  United States

Washington
      CCOP - Northwest, Tacoma,  Washington,  98405-0986,  United States

      CCOP - Virginia Mason Research Center, Seattle,  Washington,  98101,  United States

      Swedish Cancer Institute, Seattle,  Washington,  98104,  United States

      Veterans Affairs Medical Center - Seattle, Seattle,  Washington,  98108,  United States

Study chairs or principal investigators

Alton V. Hallum, III,  Study Chair,  Southwest Oncology Group   

More Information

Study ID Numbers:  CDR0000066358; SWOG-9717; SWOG-S9717
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003369
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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