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

This study is no longer recruiting patients.

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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with cisplatin and vinorelbine in treating patients with refractory or recurrent squamous cell cervical cancer that has not responded to local therapy.

Condition Treatment or Intervention Phase
recurrent cervical cancer
cervical squamous cell carcinoma
 Drug: cisplatin
 Drug: vinorelbine
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 Cisplatin/Vinorelbine in Recurrent Squamous Cell Cancer of the Cervix

Further Study Details: 

Study start: August 1997

OBJECTIVES: I. Determine the response/remission rate, duration of response, time to treatment failure, and survival of patients with advanced or recurrent squamous cell carcinoma of the cervix treated with cisplatin and vinorelbine.

PROTOCOL OUTLINE: 2-Drug Combination Chemotherapy. Cisplatin, CDDP, NSC-19875; Vinorelbine, VNB, NSC-608210.

PROJECTED ACCRUAL: 62 patients will be entered over approximately 20 months; if fewer than 7 of the first 28 patients respond, the study will be closed.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: No prior cytotoxic chemotherapy except when used for radiosensitization
  • Endocrine therapy: Not specified
  • Radiotherapy: Recovered from the effects of prior radiotherapy
  • Surgery: Recovered from the effects of prior surgery

--Patient Characteristics--

  • Age: Not specified
  • Performance status: GOG 0-2 (Karnofsky 50%-100%)
  • Hematopoietic: WBC at least 3,000; AGC at least 1,500 Platelets at least 100,000
  • Hepatic: Bilirubin no greater than 1.5 times normal; AST no greater than 3 times normal; Alkaline phosphatase no greater than 3 times normal
  • Renal: Creatinine no greater than 1.4 mg/dL; Creatinine clearance at least 50 mL/min if creatinine greater than 1.2 mg/dL
  • Other: No clinically significant infection; No significant, pre-existing peripheral neuropathy other than that associated with cancer; No prior or concomitant malignancy other than nonmelanomatous skin cancer; No other conditions that would preclude study compliance

Location Information


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

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

Maryland
      Johns Hopkins Oncology Center, Baltimore,  Maryland,  21231,  United States

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

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

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

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

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

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

Study chairs or principal investigators

Mitchell Morris,  Study Chair,  Gynecologic Oncology Group   

More Information

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

Study ID Numbers:  CDR0000064956; GOG-76Z
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002813
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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