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

June 20, 2013 updated by: Gynecologic Oncology Group

A Phase II Trial of ZD1839 (Iressa) (NSC# 715055) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • 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.

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 1450
        • Australia New Zealand Gynaecological Oncology Trials Group
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center - Calgary
  • United Kingdom
    • England
      • Birmingham, England, United Kingdom, B15 2TT
        • University of Birmingham
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • California
      • Los Angeles, California, United States, 90095-1781
        • Jonsson Comprehensive Cancer Center, UCLA
      • Los Gatos, California, United States, 95032
        • Community Hospital of Los Gatos
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center
    • Colorado
      • Denver, Colorado, United States, 80010
        • University of Colorado Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20307-5000
        • Walter Reed Army Medical Center
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60637-1470
        • University of Chicago Cancer Research Center
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202-5289
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242-1009
        • Holden Comprehensive Cancer Center at the University of Iowa
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • Medical Oncology Clinical Research Unit
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts University School of Medicine
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Cancer Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic 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
      • Columbia, Missouri, United States, 65203
        • Ellis Fischel Cancer Center - Columbia
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • 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
      • Buffalo, New York, United States, 14263-0001
        • Roswell Park Cancer Institute
      • Manhasset, New York, United States, 11030
        • Schneider Children's Hospital at North Shore
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center
      • Stony Brook, New York, United States, 11790-7775
        • 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 at Wake Forest University
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0502
        • Barrett Cancer Center, The University Hospital
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Taussig Cancer Center
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
      • Columbus, Ohio, United States, 43210-1240
        • Arthur G. James Cancer Hospital - Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73190
        • University of Oklahoma College of Medicine
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Abington Memorial Hospital
      • Hershey, Pennsylvania, United States, 17033-0850
        • Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104-4283
        • University of Pennsylvania Cancer Center
      • Philadelphia, Pennsylvania, United States, 19107-5541
        • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425-0721
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Brookview Research, Inc.
    • Texas
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Fletcher Allen Health Care - Medical Center Campus
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Cancer Center at the University of Virginia
    • Washington
      • Seattle, Washington, United States, 98109-1024
        • Fred Hutchinson Cancer Research 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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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

August 1, 2001

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 13, 2001

First Submitted That Met QC Criteria

October 14, 2003

First Posted (Estimate)

October 15, 2003

Study Record Updates

Last Update Posted (Estimate)

June 24, 2013

Last Update Submitted That Met QC Criteria

June 20, 2013

Last Verified

August 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068852
  • GOG-0170C

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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