Imatinib Mesylate (Gleevec) and Paclitaxel in Recurrent Patients of Ovarian and Other Cancers of Mullerian Origin
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms
Intervention: Gleevec/Paclitaxel
Intervention description: One treatment cycle:
Gleevec: 300 mg twice a day orally for 4 consecutive days, then off for 3 days, every 7 days for 28 days.
Paclitaxel: 80 mg/m^2/week intravenously, 3 weeks on, one week off, every 28 days.
After 3 treatment cycles, decision made to continue or not with the combination based on tolerance and lack of progression.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian cancer; recurrent; Gleevec; Paclitaxel; Taxane; mullerian

Summary:

      This study is designed to determine whether the combination treatment of Paclitaxel and
      Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will
      generate better clinical response than Paclitaxel alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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
             thrombocytopenia.

          -  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
             progressing.

          -  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).