Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Objectives

1. 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.
2. Determine the toxicity of this drug in these patients.
3. Correlate, preliminarily, CD117 and platelet-derived growth factor receptor expression levels with response in patients treated with this drug.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• 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])

Chemotherapy:

• See Disease Characteristics
• 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

Endocrine therapy:

• Prior hormonal therapy allowed

Radiotherapy:

• Recovered from prior radiotherapy
• No prior radiotherapy to more than 25% of bone marrow
• No concurrent radiotherapy

Surgery:

• 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

Other:

• 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

Patient Characteristics:

Age:

• Not specified

Performance status:

• Zubrod 0-1

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT or SGPT no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No New York Heart Association class III or IV heart disease (e.g., congestive heart failure or myocardial infarction within the past 2 months)

Other:

• 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

Expected Enrollment

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

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.

Alberts DS, Liu PY, Wilczynski SP, et al.: Phase II trial of imatinib mesylate in recurrent, biomarker positive, ovarian cancer (Southwest Oncology Group Protocol S0211). Int J Gynecol Cancer 17 (4): 784-8, 2007 Jul-Aug.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

David Alberts, MD, Protocol chair		Ph: 520-626-7685; 800-622-2673

Registry Information
Official Title		A Phase II Trial Of STI571 For The Treatment Of Platinum And Paclitaxel Refractory Stage III And IV Epithelial Ovarian Cancer And Primary Peritoneal Cancer
Trial Start Date		2002-05-31
Trial Completion Date		2007-08-01
Registered in ClinicalTrials.gov		NCT00036751
Date Submitted to PDQ		2002-03-06
Information Last Verified		2004-08-26
NCI Grant/Contract Number		CA32102

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