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

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Brief Title

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

Official Title

EVALUATION OF PACLITAXEL (TAXOL) IN PERSISTENT OR RECURRENT NON-SQUAMOUS CELL CARCINOMA OF THE CERVIX AND VAGINA

Brief Summary

      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.
    

Detailed Description

      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 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.
    

Study Phase

Phase 2

Study Type

Interventional




Condition

Cervical Cancer

Intervention

paclitaxel


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

March 1994

Completion Date

August 2004


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
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

John P. Curtin, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00002562

Organization ID

CDR0000063506

Secondary IDs

GOG-128B


Study Sponsor

Gynecologic Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

John P. Curtin, MD, Study Chair, Memorial Sloan Kettering Cancer Center


Verification Date

December 2005