Imatinib Mesylate in Treating Patients With Persistent or Recurrent Ovarian Epithelial or Primary Peritoneal Cancer
Primary Peritoneal Cavity Cancer, Recurrent Ovarian Epithelial Cancer
About this trial
This is an interventional treatment trial for Primary Peritoneal Cavity Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed ovarian epithelial or primary peritoneal carcinoma Recurrent or persistent disease At least 1 unidimensionally measurable target lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Tumors within a previously irradiated field considered nontarget lesions At least one prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or another organoplatinum compound) for primary disease required Initial treatment may include high-dose, consolidation, or extended therapy Initial treatment-free interval less than 12 months for patients who received only 1 prior platinum-based regimen Initial treatment-free interval of more than 12 months allowed provided disease progression has occurred within 12 months after retreatment with a second-line platinum-based regimen Ineligible for a higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population) Performance status - GOG 0-2 (if patient has received one prior treatment regimen) Performance status - GOG 0-1 (if patient has received two prior treatment regimens) Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT/SGPT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Creatinine no greater than 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 3 months after study participation No active infection requiring antibiotics No greater than grade 1 sensory and motor neuropathy No other invasive malignancy within the past 5 years except nonmelanoma skin cancer No signs or symptoms of bowel dysfunction At least 3 weeks since prior immunologic therapy directed at the malignant tumor No concurrent biologic therapy or immunotherapy for the malignant tumor Recovered from prior chemotherapy No prior noncytotoxic chemotherapy for persistent or recurrent disease One additional cytotoxic regimen for persistent or recurrent disease allowed No concurrent chemotherapy for the malignant tumor At least 1 week since prior hormonal therapy directed at the malignant tumor No concurrent therapeutic corticosteroids No concurrent anticancer hormonal therapy Concurrent hormone replacement therapy allowed Recovered from prior radiotherapy No prior radiotherapy to more than 25% of marrow-bearing areas No concurrent anticancer radiotherapy Recovered from recent prior surgery At least 3 weeks since other prior therapies directed at the malignant tumor No prior imatinib mesylate No prior anticancer therapy that would preclude study participation No concurrent therapeutic anticoagulation with warfarin No other concurrent investigational drugs No concurrent amifostine or other protective reagents
Sites / Locations
- Gynecologic Oncology Group
Arms of the Study
Arm 1
Experimental
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.