Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal Cancer

April 10, 2013 updated by: Gynecologic Oncology Group

Evaluation of Docetaxel in Recurrent, Platinum Resistant, Refractory and Paclitaxel Refractory Ovarian Cancer and Primary Peritoneal Carcinoma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Peter G. Rose, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

June 24, 2003

First Posted (Estimate)

June 25, 2003

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

May 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000066369
  • GOG-126J

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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