Gleevec and Gemzar in Patients With Epithelial Ovarian Cancer
Condition: Ovarian Cancer; Primary Peritoneal Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: imatinib mesylate by mouth; Gemcitabine Intravenous
Intervention description: imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle.; Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle
Intervention MeSH terms: Gemcitabine; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ovarian; cancer; peritoneal; endometrioid; mucinous; serous; clear cell

Summary:

      This study will evaluate the efficacy and tolerability of the combination of Gleevec and
      Gemzar in patients with ovarian cancer, who have progressed after receiving at least one
      prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and
      Gemzar is an IV chemotherapy drug used. Participation in the treatment portion of the study
      will continue as long as the patient's tumors shrink or remain stable and as long as the
      patient is able to tolerate the study drug. The follow-up portion of the study will last for
      5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age or greater

          -  Histologically documented diagnosis of ovarian cancer or primary peritoneal cancer.
             Histological subtypes include: mucinous tumor, serous tumor, endometrioid tumor, and
             other histologies including clear cell and undifferentiated epithelial tumors.

          -  At least one measurable site of disease (as defined by Southwestern Oncology Group
             Solid Tumor Response Criteria) or other response assessment criteria, as appropriate.

          -  Patients must have relapsed after receiving at least one prior platinum-based
             chemotherapy.

          -  Performance status of 0, 1, 2, (ECOG)

          -  Adequate end organ function: Total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 UNL,
             creatinine < 1.5 x UNL, ANC > 1.5 x 109/L, platelets > 100 x 109/L.

          -  Patients will most likely have had their ovaries removed at the time off initial
             surgery. If any subjects are of childbearing potential at the time of entry, they must
             have negative pregnancy test within 7 days before initiation of study drug dosing.
             Postmenopausal women must be amenorrheic for at least 12 months to be considered of
             non-childbearing potential. Subjects of reproductive potential must agree to employ
             and effective barrier method of birth control throughout the study and for up to 3
             months following discontinuation of the study drug.

          -  Written, voluntary informed consent.

          -  Patients must be eligible for care at a military medical treatment facility.

        Exclusion Criteria:

          -  Patient has received prior treatment with Gemzar.

          -  Patient has received any other investigational agents within 28 days of the first day
             of study drug dosing.

          -  Patient is < 5 years free of another primary malignancy except: if the other primary
             malignancy is neither currently clinically significant nor requiring active
             intervention, or if other primary malignancy is a basal cell skin cancer or a cervical
             carcinoma in situ. Existence of any other malignant disease is not allowed.

          -  Patient with Grade III/IV cardiac problems as defined but the New York Heart
             Association Criteria.

          -  Patients who are pregnant or breast-feeding.

          -  Patient has a severe and/or uncontrolled medical disease (i,e. uncontrolled diabetes,
             uncontrolled chronic renal disease, or active uncontrolled infection).

          -  Patient has a known untreated or progressive brain metastasis.

          -  Patient has known chronic liver diseases (i.e. chronic active hepatitis, and
             cirrhosis.

          -  Patient has a known diagnosis of human immunodeficiency virus (HIV infection ).

          -  Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C)
             prior to study entry, unless the disease is rapidly progressing..

          -  Patient previously received radiotherapy to greater than or equal to 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.