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
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
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
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.
Inclusion Criteria:
Histologically confirmed epithelial carcinoma of the ovary or primary peritoneal serous papillary carcinoma
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
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