Gefitinib in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

NCT00023699 | Completed Phase 2

• 2 other identifiers: CDR0000068852GOG-0170C
• Study Type: interventional
• Target: N/A
• Locations: 4 countries
• Sites: 53

Brief Summary

RATIONALE: Biological therapies such as gefitinib may interfere with the growth of the tumor cells and may slow the growth of ovarian epithelial cancer or primary peritoneal cancer. 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.

Conditions

Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; primary peritoneal cavity cancer

Interventions

gefitinib DRUG

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal carcinoma * Recurrent or persistent disease * Must have had prior therapy with no more than 1 platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease * Platinum-resistant or refractory * Treatment-free interval of less than 6 months after therapy with platinum-containing regimen OR * Progression during platinum-containing regimen OR * Platinum sensitive defined as treatment-free interval without disease progression for more than 6 months but less than 12 months after therapy with platinum-containing regimen * At least 1 lesion measurable in at least 1 dimension * At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR * At least 10 mm by spiral CT scan * At least 1 target lesion outside a previously irradiated field * Disease must be accessible to core needle biopsy * Ineligible for higher priority GOG protocol PATIENT CHARACTERISTICS: 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (53)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Community Hospital of Los Gatos

Los Gatos, California, 95032, United States

Location

Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

University of Colorado Cancer Center

Denver, Colorado, 80010, United States

Location

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Holden Comprehensive Cancer Center at The University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

Albert B. Chandler Medical Center, University of Kentucky

Lexington, Kentucky, 40536-0084, United States

Location

Medical Oncology Clinical Research Unit

Bethesda, Maryland, 20892, United States

Location

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Keesler Medical Center - Keesler AFB

Keesler Air Force Base, Mississippi, 39534-2576, United States

Location

Ellis Fischel Cancer Center - Columbia

Columbia, Missouri, 65203, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Cooper Hospital/University Medical Center

Camden, New Jersey, 08103, United States

Location

Cancer Center of Albany Medical Center

Albany, New York, 12208, United States

Location

State University of New York Health Science Center at Brooklyn

Brooklyn, New York, 11203, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Schneider Children's Hospital at North Shore

Manhasset, New York, 11030, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

State University of New York Health Sciences Center - Stony Brook

Stony Brook, New York, 11790-7775, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1082, United States

Location

Barrett Cancer Center, The University Hospital

Cincinnati, Ohio, 45267-0502, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210-1240, United States

Location

University of Oklahoma College of Medicine

Oklahoma City, Oklahoma, 73190, United States

Location

Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Brookview Research, Inc.

Nashville, Tennessee, 37203, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Fletcher Allen Health Care - Medical Center Campus

Burlington, Vermont, 05401, United States

Location

Cancer Center at the University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Tacoma General Hospital

Tacoma, Washington, 98405, United States

Location

Australia New Zealand Gynaecological Oncology Trials Group

Camperdown, New South Wales, 1450, Australia

Location

Tom Baker Cancer Center - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

University of Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 16061871 RESULT

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Russell J. Schilder, MD

  Fox Chase Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: September 13, 2001
• First Posted: October 15, 2003
• Study Start: August 1, 2001
• Study Completion: May 1, 2006
• Last Updated: June 24, 2013

Record last verified: 2003-08

Locations

GB (1); US (50); AU (1); CA (1)