Topotecan in Treating Patients With Recurrent Ovarian Epithelial or Primary Peritoneal Cancer

April 11, 2018 updated by: Gynecologic Oncology Group

Phase II Evaluation of Three-Day Topotecan (NSC 609699) in Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

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 topotecan in treating patients who have recurrent ovarian epithelial or primary peritoneal cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the antitumor activity of topotecan in patients with recurrent platinum sensitive ovarian epithelial or primary peritoneal cancer. II. Determine the nature and degree of toxicity of this treatment regimen in these patients.

OUTLINE: Patients receive topotecan IV over 30 minutes on days 1-3. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 22-60 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
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • MBCCOP - Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612-7323
        • MBCCOP - University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, United States, 60637
        • University of Chicago Cancer Research Center
      • Decatur, Illinois, United States, 62526
        • CCOP - Central Illinois
      • Evanston, Illinois, United States, 60201
        • CCOP - Evanston
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5265
        • Indiana University Cancer Center
    • Iowa
      • Des Moines, Iowa, United States, 50309-1016
        • CCOP - Iowa Oncology Research Association
      • 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
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Medicine
      • 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 Air Force Base, Mississippi, United States, 39534-2576
        • Keesler Medical Center - Keesler AFB
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center
      • Kansas City, Missouri, United States, 64131
        • CCOP - Kansas City
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
      • Springfield, Missouri, United States, 65807
        • CCOP - Cancer Research for the Ozarks
    • 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
      • Wynnewood, Pennsylvania, United States, 19096
        • CCOP - MainLine Health
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Medical University of South Carolina
      • Greenville, South Carolina, United States, 29615
        • CCOP - Greenville
      • 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
      • Temple, Texas, United States, 76508
        • CCOP - Scott and White Hospital
    • 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

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS: Histologically confirmed recurrent ovarian epithelial or primary peritoneal carcinoma Bidimensionally measurable disease (ascites and pleural effusions not considered measurable) Platinum sensitive (defined as treatment free interval following response to platinum of greater than 6 months) One prior platinum based chemotherapy regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound required

PATIENT CHARACTERISTICS: Age: Not specified Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT and alkaline phosphatase no greater that 2.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: No active infection requiring antibiotics No neuropathy greater than grade 1 Not pregnant Negative pregnancy test Fertile patients must use effective contraception No prior malignancy within past 5 years except nonmelanoma skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic or immunologic agents Chemotherapy: See Disease Characteristics Recovered from prior chemotherapy Patients with no prior paclitaxel therapy may receive second regimen that includes paclitaxel No other prior or concurrent cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens No prior topotecan Endocrine therapy: At least one week since prior hormonal therapy for malignant tumor Prior and concurrent hormone replacement therapy allowed Radiotherapy: No prior or concurrent radiotherapy to target sites No prior radiotherapy to greater than 25% of bone marrow Recovered from prior radiotherapy Surgery: Recovered from prior surgery Other: No prior cancer treatment that contraindicates study

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)

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

February 1, 2000

Primary Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

April 6, 2000

First Submitted That Met QC Criteria

July 16, 2004

First Posted (Estimate)

July 19, 2004

Study Record Updates

Last Update Posted (Actual)

April 12, 2018

Last Update Submitted That Met QC Criteria

April 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067550
  • GOG-0146K

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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