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

NCT ID: NCT00036751

Last Updated: 2013-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30

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

Detailed Description

OBJECTIVES:

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.

Conditions

Primary Peritoneal Cavity Cancer; Recurrent Ovarian Epithelial Cancer; Stage III Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (imatinib mesylate)

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

Group Type: EXPERIMENTAL

imatinib mesylate

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

Correlative studies

Interventions

imatinib mesylate

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

Correlative studies

Intervention Type: OTHER

Other Intervention Names

CGP 57148; Gleevec; Glivec

Eligibility Criteria

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Alberts

Role: PRINCIPAL_INVESTIGATOR

SWOG Cancer Research Network

Locations

Southwest Oncology Group (SWOG) Research Base

San Antonio, Texas, United States

Countries

United States

Other Identifiers

SWOG-S0211

Identifier Type: -

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000069319

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2012-02463

Identifier Type: -

Identifier Source: org_study_id