COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Imatinib Mesylate in Treating Patients With Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00036751
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : January 24, 2013
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage III or stage IV ovarian epithelial or primary peritoneal cancer that has not responded to previous treatment. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth

Condition or disease Intervention/treatment Phase
Primary Peritoneal Cavity Cancer Recurrent Ovarian Epithelial Cancer Stage III Ovarian Epithelial Cancer Stage IV Ovarian Epithelial Cancer Drug: imatinib mesylate Other: laboratory biomarker analysis Phase 2

Detailed Description:


I. Determine the response rates (confirmed, complete, and partial) in patients with platinum- and taxane-refractory stage III or IV ovarian epithelial or primary peritoneal cancer treated with imatinib mesylate.

II. Determine the toxicity of this drug in these patients. III. Correlate, preliminarily, CD117 and platelet-derived growth factor receptor expression levels with response in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of STI571 For The Treatment Of Platinum And Taxane Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer
Study Start Date : April 2002
Actual Primary Completion Date : August 2007

Arm Intervention/treatment
Experimental: Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Response rate (complete and partial confirmed response) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Toxicity as assessed by NCI Common Toxicity Criteria version 2.0 [ Time Frame: Up to 3 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma

    • No mixed Mullerian tumors
    • No borderline ovarian tumors
  • Stage III or IV disease at time of diagnosis by surgical staging
  • Expression of KIT (CD117) and/or platelet-derived growth factor receptor by immunohistochemistry
  • Relapsed within 6 months after completion of or progressed while receiving prior frontline chemotherapy with a platinum (cisplatin or carboplatin) and a taxane(paclitaxel or docetaxel) administered concurrently or sequentially
  • Measurable disease
  • Performance status - Zubrod 0-1
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
  • At least 28 days since prior biologic therapy
  • No concurrent anticancer biologic therapy
  • No concurrent cytokines (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
  • At least 28 days since prior chemotherapy
  • No more than 3 prior chemotherapy regimens in addition to frontline chemotherapy

    • Retreatment with a platinum agent or with the same taxane as in the frontline regimen is not counted as an additional regimen
  • No concurrent chemotherapy
  • Prior hormonal therapy allowed
  • Recovered from prior radiotherapy
  • No prior radiotherapy to more than 25% of bone marrow
  • No concurrent radiotherapy
  • Prior surgical debulking allowed for relapsed disease if measurable disease remains after surgery
  • At least 14 days since prior major surgery
  • Recovered from all prior surgery
  • At least 28 days since prior investigational drugs
  • No concurrent therapeutic doses of warfarin for anticoagulation (heparin or mini-dose warfarin (1 mg/day) allowed)
  • No other concurrent anticancer agents
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00036751

Layout table for location information
United States, Texas
Southwest Oncology Group (SWOG) Research Base
San Antonio, Texas, United States, 78245
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: David Alberts Southwest Oncology Group

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI) Identifier: NCT00036751    
Other Study ID Numbers: NCI-2012-02463
U10CA032102 ( U.S. NIH Grant/Contract )
CDR0000069319 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Ovarian Epithelial
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action