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


Phase 2
N/A
N/A
Not Enrolling
Female
Cervical Cancer, Vaginal Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John P. Curtin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000063506

NCT ID:

NCT00002562

Start Date:

March 1994

Completion Date:

August 2004

Related Keywords:

  • Cervical Cancer
  • Vaginal Cancer
  • recurrent cervical cancer
  • recurrent vaginal cancer
  • vaginal clear cell adenocarcinoma
  • cervical adenocarcinoma
  • Uterine Cervical Neoplasms
  • Vaginal Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Stanford University Medical CenterStanford, California  94305-5408
University of Colorado Cancer CenterDenver, Colorado  80262
Vincent T. Lombardi Cancer Research Center, Georgetown UniversityWashington, District of Columbia  20007
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
Cooper Hospital/University Medical CenterCamden, New Jersey  08103
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157-1082
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Cleveland Clinic Cancer CenterCleveland, Ohio  44195
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
University of Oklahoma College of MedicineOklahoma City, Oklahoma  73190
Abington Memorial HospitalAbington, Pennsylvania  19001
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Medical University of South CarolinaCharleston, South Carolina  29425-0721
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Simmons Cancer Center - DallasDallas, Texas  75235-9154
Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
University of Washington Medical CenterSeattle, Washington  98195-6043
Tacoma General HospitalTacoma, Washington  98405
Women's Cancer CenterPalo Alto, California  94304
Pennsylvania HospitalPhiladelphia, Pennsylvania  19107