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 paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.

Condition	Treatment or Intervention	Phase
recurrent vaginal cancer recurrent cervical cancer cervical adenocarcinoma vaginal clear cell adenocarcinoma	Drug: paclitaxel	Phase II

Further Study Details: 

OBJECTIVES: I. Estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols.

II. Determine the frequency and severity of observed adverse effects on this study.

PROTOCOL OUTLINE: Single-Agent Chemotherapy. Paclitaxel, TAX, NSC-673089.

PROJECTED ACCRUAL: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. If more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. As of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina or cervix
• Documented disease progression after local therapy required; Disease must be considered incurable
• Bidimensionally measurable disease required by physical examination or medical imaging

--Prior/Concurrent Therapy--

• At least 3 weeks since therapy directed at malignancy
• Biologic therapy: Not specified
• Chemotherapy: No more than 1 prior chemotherapy regimen (either single or combination cytotoxic drug therapy); No prior paclitaxel; Recovery from prior chemotherapy required
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy for recurrent disease except a low dose, single fraction used to abrogate menorrhagia; Recovery from prior radiotherapy required
• Surgery: Recovery from prior surgery required

--Patient Characteristics--

• Age: Any age
• Performance status: GOG 0-2
• Hematopoietic: WBC at least 3,000; AGC at least 1,500; Platelets at least 100,000
• Hepatic: Bilirubin no more than 1.5 times normal; AST no more than 3 times normal; Alkaline phosphatase no more than 3 times normal
• Renal: Creatinine no more than 2.0 mg/dL
• Other: Not eligible for a higher priority GOG protocol; No significant infection; No prior or concomitant second malignancy except nonmelanomatous skin cancer

Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States
California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States
      Stanford University Medical Center, Stanford,  California,  94305-5408,  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
      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
      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
Massachusetts
      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
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States
Missouri
      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  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
      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,  11790-9832,  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
      University of Oklahoma College of Medicine, Oklahoma City,  Oklahoma,  73190,  United States
Pennsylvania
      Abington Memorial Hospital, Abington,  Pennsylvania,  19001,  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
      Pennsylvania Hospital, Philadelphia,  Pennsylvania,  19107,  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
Texas
      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

Study chairs or principal investigators

John P. Curtin,  Study Chair,  Gynecologic Oncology Group   

Study ID Numbers:  CDR0000063506; GOG-128B
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002562
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08