Search / Trial NCT00002562

Paclitaxel in Treating Patients With Advanced, Refractory, or Recurrent Cervical or Vaginal Cancer

Launched by GYNECOLOGIC ONCOLOGY GROUP · Aug 9, 2004

Trial Information

Current as of December 07, 2024

Completed

Keywords

Recurrent Cervical Cancer Recurrent Vaginal Cancer Vaginal Clear Cell Adenocarcinoma Cervical Adenocarcinoma

ClinConnect Summary

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.

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 ...

Gender

FEMALE

Eligibility 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
  • 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
  • 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

Trial Officials

John P. Curtin, MD

Study Chair

Memorial Sloan Kettering Cancer Center

About Gynecologic Oncology Group

The Gynecologic Oncology Group (GOG) is a leading clinical trial sponsor dedicated to advancing the understanding and treatment of gynecologic cancers. Comprising a network of experts in the field, GOG conducts rigorous, multi-institutional research to evaluate innovative therapeutic strategies and improve patient outcomes. Through its commitment to high-quality clinical trials, the organization aims to enhance the standard of care for women diagnosed with gynecologic malignancies, fostering collaborations with academic institutions and industry partners to translate scientific discoveries into effective treatments. GOG's mission emphasizes patient safety, ethical research practices, and the dissemination of findings to benefit the broader medical community.

Locations

New York, New York, United States

Houston, Texas, United States

Birmingham, Alabama, United States

Los Angeles, California, United States

Los Angeles, California, United States

Stanford, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Washington, District Of Columbia, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Iowa City, Iowa, United States

Lexington, Kentucky, United States

Baltimore, Maryland, United States

Worcester, Massachusetts, United States

Ann Arbor, Michigan, United States

Detroit, Michigan, United States

Minneapolis, Minnesota, United States

Jackson, Mississippi, United States

Saint Louis, Missouri, United States

Camden, New Jersey, United States

Albany, New York, United States

Brooklyn, New York, United States

Rochester, New York, United States

Stony Brook, New York, United States

Chapel Hill, North Carolina, United States

Durham, North Carolina, United States

Winston Salem, North Carolina, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Cleveland, Ohio, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Abington, Pennsylvania, United States

Hershey, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Spartanburg, South Carolina, United States

Dallas, Texas, United States

Charlottesville, Virginia, United States

Seattle, Washington, United States

Tacoma, Washington, United States

Palo Alto, California, United States

Philadelphia, Pennsylvania, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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