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Ovarian CancerPhase 2NCT00023699

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

A Phase 2 study testing gefitinib in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 53 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
gefitinib
How many people
Not given
Where
53 sitesin 4 countries
Study dates
Aug 2001to May 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

53 sites in 4 countries.

53 sites in 4 countries

United States50 sites

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • Medical Oncology Clinical Research Unit

    Bethesda, Maryland, 20892

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111

  • State University of New York Health Science Center at Brooklyn

    Brooklyn, New York, 11203

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Fletcher Allen Health Care - Medical Center Campus

    Burlington, Vermont, 05401

  • Cooper Hospital/University Medical Center

    Camden, New Jersey, 08103

  • Lineberger Comprehensive Cancer Center, UNC

    Chapel Hill, North Carolina, 27599-7295

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60637-1470

  • Barrett Cancer Center, The University Hospital

    Cincinnati, Ohio, 45267-0502

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Ellis Fischel Cancer Center - Columbia

    Columbia, Missouri, 65203

  • Arthur G. James Cancer Hospital - Ohio State University

    Columbus, Ohio, 43210-1240

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • University of Colorado Cancer Center

    Denver, Colorado, 80010

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201-1379

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • Holden Comprehensive Cancer Center at The University of Iowa

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • Albert B. Chandler Medical Center, University of Kentucky

    Lexington, Kentucky, 40536-0084

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Community Hospital of Los Gatos

    Los Gatos, California, 95032

  • Schneider Children's Hospital at North Shore

    Manhasset, New York, 11030

  • University of Minnesota Cancer Center

    Minneapolis, Minnesota, 55455

  • Brookview Research, Inc.

    Nashville, Tennessee, 37203

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • University of Oklahoma College of Medicine

    Oklahoma City, Oklahoma, 73190

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • University of Pennsylvania Cancer Center

    Philadelphia, Pennsylvania, 19104-4283

  • Kimmel Cancer Center of Thomas Jefferson University - Philadelphia

    Philadelphia, Pennsylvania, 19107-5541

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • Tacoma General Hospital

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612-9497

  • Walter Reed Army Medical Center

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

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Australia1 site

  • Australia New Zealand Gynaecological Oncology Trials Group

    Camperdown, New South Wales, 1450

Other trials in Australia

Canada1 site

  • Tom Baker Cancer Center - Calgary

    Calgary, Alberta, T2N 4N2

Other trials in Canada

United Kingdom1 site

  • University of Birmingham

    Birmingham, England, B15 2TT

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
gefitinib
Keywords
recurrent ovarian epithelial cancer, primary peritoneal cavity cancer
Medical subject headings
Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2003 (estimated)
  2. Study startAug 2001
  3. Study completionMay 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
IDs, dates and publications
ClinicalTrials.gov ID
NCT00023699
Sponsor's protocol ID
CDR0000068852
Other IDs
GOG-0170C
Status last verified
Aug 2003
First submitted
13 Sep 2001
Last updated
24 Jun 2013
Results posted
No

Publications

  • 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.

    PubMed 16061871

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gefitinib in people with Ovarian Cancer and Primary Peritoneal Cavity Cancer, run by Gynecologic Oncology Group at 53 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Australia, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00023699, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.

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