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
Overview
- Phase
- Phase 2
- Intervention
- imatinib mesylate
- Conditions
- Primary Peritoneal Cavity Cancer
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Response rate (complete and partial confirmed response)
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Intervention: imatinib mesylate
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Response rate (complete and partial confirmed response)
Time Frame: Up to 3 years
Secondary Outcomes
- Toxicity as assessed by NCI Common Toxicity Criteria version 2.0(Up to 3 years)