Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
NCT ID: NCT00023699
Last Updated: 2013-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2001-08-31
2006-05-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have recurrent or persistent ovarian epithelial cancer or primary peritoneal cancer.
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Detailed Description
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* Determine the antitumor cytostatic activity of gefitinib, in terms of 6-month progression-free survival, in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.
* Determine the nature and degree of toxicity in patients treated with this drug.
* Determine the partial and complete response rates in patients treated with this drug.
* Determine the duration of progression-free and overall survival in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 1-2 years.
Conditions
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Study Design
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TREATMENT
Interventions
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gefitinib
Eligibility Criteria
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Inclusion Criteria
Age:
* Not specified
Performance status:
* GOG 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
Renal:
* Creatinine no greater than 1.5 times ULN
Cardiovascular:
* No unstable cardiac disease
* No myocardial infarction within the past 6 months
* Coronary artery disease, congestive heart failure, and dysrhythmia allowed if on stable regimen for at least 3 months
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No sensory or motor neuropathy greater than grade 1
* No active corneal disease (e.g., keratoconjunctivitis)
* No active infection requiring antibiotics
* No evidence of bowel dysfunction that could be related to early bowel obstruction
* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 3 weeks since prior immunological agents for the malignancy
* No concurrent anti-cancer immunotherapy
Chemotherapy:
* See Disease Characteristics
* No more than 1 additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease
* No prior noncytotoxic chemotherapy for recurrent or persistent disease
* At least 3 weeks since prior chemotherapy for the malignancy and recovered
* No concurrent anti-cancer chemotherapy
Endocrine therapy:
* At least 1 week since prior anticancer hormonal therapy
* Concurrent hormone replacement therapy allowed
* No concurrent anti-cancer hormonal therapy
Radiotherapy:
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy for the malignancy and recovered
* No prior radiotherapy to more than 25% of marrow-bearing areas
* No concurrent anti-cancer radiotherapy
Surgery:
* At least 4 weeks since prior surgery (except minor procedures under local anesthesia (e.g., central venous port placement)) and recovered
Other:
* At least 3 weeks since other prior therapy for the malignancy
* No prior gefitinib
* No other prior epidermal growth factor receptor inhibitors
* No prior anticancer therapy that would preclude study therapy
* No concurrent chlorpromazine
* No other concurrent investigational agents
* No other concurrent antineoplastic agents
* No concurrent CYP3A4-inducing agents, including phenytoin, carbamazepine, barbiturates, nafcillin, rifampicin, or St. John's Wort
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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Russell J. Schilder, MD
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Community Hospital of Los Gatos
Los Gatos, California, United States
Chao Family Comprehensive Cancer Center
Orange, California, United States
University of Colorado Cancer Center
Denver, Colorado, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, United States
Medical Oncology Clinical Research Unit
Bethesda, Maryland, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Keesler Medical Center - Keesler AFB
Keesler Air Force Base, Mississippi, United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cooper Hospital/University Medical Center
Camden, New Jersey, United States
Cancer Center of Albany Medical Center
Albany, New York, United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Schneider Children's Hospital at North Shore
Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States
Ireland Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Brookview Research, Inc.
Nashville, Tennessee, United States
Simmons Cancer Center - Dallas
Dallas, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, Australia
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada
University of Birmingham
Birmingham, England, United Kingdom
Countries
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References
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Schilder RJ, Sill MW, Chen X, Darcy KM, Decesare SL, Lewandowski G, Lee RB, Arciero CA, Wu H, Godwin AK. Phase II study of gefitinib in patients with relapsed or persistent ovarian or primary peritoneal carcinoma and evaluation of epidermal growth factor receptor mutations and immunohistochemical expression: a Gynecologic Oncology Group Study. Clin Cancer Res. 2005 Aug 1;11(15):5539-48. doi: 10.1158/1078-0432.CCR-05-0462.
Other Identifiers
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GOG-0170C
Identifier Type: -
Identifier Source: secondary_id
CDR0000068852
Identifier Type: -
Identifier Source: org_study_id
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