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

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