Full Text View
Tabular View
No Study Results Posted
Related Studies
Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Cancer
This study has been completed.
First Received: December 10, 1999   Last Updated: July 23, 2008   History of Changes
Sponsor: Gynecologic Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004037
  Purpose

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 docetaxel in treating patients with recurrent or refractory ovarian or primary peritoneal cancer.


Condition Intervention Phase
Ovarian Cancer
Peritoneal Cavity Cancer
Drug: docetaxel
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Evaluation of Docetaxel in Recurrent, Platinum Resistant, Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1998
Detailed Description:

OBJECTIVES: I. Estimate the antitumor activity of docetaxel in patients with paclitaxel- and platinum-resistant, recurrent or refractory, ovarian epithelial or primary peritoneal cancer who have failed on higher priority treatment protocols. II. Determine the nature and degree of toxicity of docetaxel in this patient population.

OUTLINE: Patients receive docetaxel as a 1 hour continuous intravenous infusion. Courses are repeated every 21 days. Treatment continues in the absence of unacceptable toxic effects or disease progression. All patients are followed every 3 months for 2 years, every 6 months for 3 years, and then until death.

PROJECTED ACCRUAL: A total of 23-56 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or refractory ovarian epithelial or peritoneal cancer Platinum resistant AND paclitaxel resistant Progressed on or within 6 months of completing therapy with paclitaxel and platinum either alone or in combination Bidimensionally measurable disease (excludes ascites and pleural effusions) Brain metastases allowed provided that other measurable disease exists and brain lesions required no therapy for 6 months and are not life threatening Not eligible for higher priority GOG protocol

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Granulocyte count at least 1,500/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No significant infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E) No other invasive malignancies within the past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Must have had at least 1 prior platinum based chemotherapeutic regimen containing carboplatin, cisplatin, or another organoplatinum compound Must have had at least 1 prior paclitaxel based chemotherapeutic regimen 1 or 2 prior chemotherapy regimens containing platinum and paclitaxel allowed Recovered from toxic effects No prior docetaxel Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Recovered from effects of recent surgery Other: At least 3 weeks since any prior therapy directed at the malignant tumor No prior cancer treatment that contraindicates this protocol therapy

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004037

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, Arizona
CCOP - Greater Phoenix
Phoenix, Arizona, United States, 85006-2726
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Women's Cancer Center
Palo Alto, California, United States, 94304
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, District of Columbia
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342-1701
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
CCOP - Central Illinois
Springfield, Illinois, United States, 62526
CCOP - Evanston
Evanston, Illinois, United States, 60201
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States, 40536-0084
United States, Maryland
Johns Hopkins Oncology Center
Baltimore, Maryland, United States, 21287
Medicine Branch
Bethesda, Maryland, United States, 20892
Radiation Oncology Branch
Bethesda, Maryland, United States, 20892
United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
United States, Nebraska
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68131
United States, Nevada
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
North Shore University Hospital
Manhasset, New York, United States, 11030
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-9832
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, North Carolina
Brookview Research, Inc.
Winston-Salem, North Carolina, United States, 27103
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Oklahoma
CCOP - St. Francis Hospital/Natalie Warren Bryant Cancer Center
Tulsa, Oklahoma, United States, 74136
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States, 38117
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
United States, Washington
Tacoma General Hospital
Tacoma, Washington, United States, 98405
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Canada, Ontario
NCIC-Clinical Trials Group
Kingston, Ontario, Canada, K7L 3N6
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Peter G. Rose, MD The Cleveland Clinic
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000066369, GOG-126J
Study First Received: December 10, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004037     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
peritoneal cavity cancer

Additional relevant MeSH terms:
Digestive System Neoplasms
Ovarian Neoplasms
Antineoplastic Agents
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Abdominal Neoplasms
Pharmacologic Actions
Adnexal Diseases
Docetaxel
Genital Diseases, Female
Neoplasms
Digestive System Diseases
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Peritoneal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009