Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
- Patients at least 18 years of age.
- Histologically documented diagnosis of epithelial carcinoma arising in the ovary,
fallopian tube or peritoneum, of any stage or grade at diagnosis. *Patients must
have received initial cytoreductive surgery and chemotherapy with at least one
platinum based chemotherapy regimen.
*Eligible platinum resistant patients will have failed no more than two additional
non platinum cytotoxic regimens for their persistent or recurrent disease.
- Measurable disease.
- Performance status 0, 1, 2 (Eastern Cooperative Oncology Group) .
- Adequate end organ function, defined as the following: total bilirubin < 1.5 x upper
limit of normal (ULN), SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 1.0 x
10E9/L, platelets > 100 x 10E9/L.
- Written, voluntary informed consent.
- Patient has received any other anticancer treatment within 21 days of first day of
study drug dosing and shown recovery of any recent drug-induced neutropenia and
- Patient has another primary malignancy that has required active intervention within 5
years, with the exception of basal cell skin cancer or a cervical carcinoma in situ.
- Patient with Grade III/IV cardiac problems as defined by the New York Heart
Association Criteria (i.e., congestive heart failure, myocardial infarction within 6
months of study).
- Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled
diabetes, chronic renal disease, or active uncontrolled infection).
- Patients on coumadin-derived anticoagulants.
- Patient with brain metastasis.
- Chronic liver disease, Hep B or C.
- Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- Patient received chemotherapy within 3 weeks -unless the disease is rapidly
- Patient previously received radiotherapy to at least 25 % of the bone marrow.
- Patient had a major surgery within 2 weeks prior to study entry.
- Patient with any significant history of non-compliance to medical regimens or with
inability to grant reliable informed consent.
- Patient is on any drug that may interfere with Gleevec (e.g., Dilantin, Coumadin,or
others on the list on page 33-37 of the protocol).