Etoposide in Treating Patients With Advanced Ovarian or Cervical Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00002478
First received: November 1, 1999
Last updated: June 7, 2013
Last verified: November 2000
  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 etoposide in treating patients who have refractory, recurrent, or metastatic ovarian or cervical cancer.


Condition Intervention Phase
Cervical Cancer
Ovarian Cancer
Drug: etoposide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Prolonged Oral VP-16 for Advanced Ovarian Epithelial and Cervical Cancer

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: June 1993
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Determine the efficacy of prolonged oral etoposide (VP-16) in patients with advanced ovarian epithelial or cervical cancer. II. Evaluate the frequency and severity of observed adverse effects in this patient population treated with prolonged oral VP-16.

OUTLINE: Patients receive etoposide by mouth once daily on days 1-21 every 4 weeks. Patients with responding disease continue treatment for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease continue treatment for up to 6 months in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: If 4-6 responses are observed in the first 25 patients, an additional 15 patients will be entered. The estimated duration of the study is 8 months.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic ovarian epithelial or cervical cancer Tissue not accessible for biopsy Refractory to curative therapy or established treatments and ineligible for higher priority GOG protocols Measurable disease required, as follows: Lesion measurable by physical exam Lesion bidimensionally measurable on sonogram or imaging Ascites/pleural effusion not measurable

PATIENT CHARACTERISTICS: Age: Any age Performance status: GOG 0-2 Hematopoietic: WBC at least 3,000/mm3 Absolute granulocyte count at least 1,500/mm3 Platelets at least 100,000/mm3 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 greater than 2.0 mg/dL Other: Body surface area at least 1 square meter No requirement for intravenous hydration or nutritional support No significant infection No second malignancy other than nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since anticancer therapy Chemotherapy: No more than 1 prior chemotherapy trial No prior etoposide At least 3 weeks since chemotherapy and recovered Endocrine therapy: At least 3 weeks since anticancer therapy Radiotherapy: At least 3 weeks since radiotherapy Surgery: At least 3 weeks since surgery and recovered

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002478

  Hide Study Locations
Locations
United States, Alabama
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Stanford University Medical Center
Stanford, California, United States, 94305-5408
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80262
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
Vincent T. Lombardi Cancer Research Center, Georgetown University
Washington, District of Columbia, United States, 20007
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
MBCCOP - Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
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
United States, Massachusetts
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, United States, 48106
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
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
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
University of Rochester Cancer Center
Rochester, New York, United States, 14642
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States, 11790-7775
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
United States, Ohio
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
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States, 73190
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States, 29303
United States, Texas
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
United States, Virginia
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
Tacoma General Hospital
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Gynecologic Oncology Group
Investigators
Study Chair: Peter G. Rose, MD University Hospitals Seidman Cancer Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00002478     History of Changes
Other Study ID Numbers: CDR0000077078, GOG-26LL
Study First Received: November 1, 1999
Last Updated: June 7, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
recurrent cervical cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Uterine Cervical Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Etoposide
Etoposide phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 29, 2014