Gleevec Study for Patients With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Imatinib Mesylate
Intervention description: 600 mg by mouth daily for 6 Weeks
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ovarian Cancer; Primary Peritoneal Cancer; Fallopian Tube Cancer; Recurrent Platinum-Resistant; Taxane-Resistant; Epithelial Ovarian Cancer; Imatinib Mesylate; Gleevec; STI571; Protein tyrosine kinase inhibitor

Summary:

      Primary Objectives:

        1. To determine the efficacy of Gleevec in patients with recurrent platinum-resistant,
           taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube
           cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor
           (PDGRF), or ABL.

        2. To determine the nature and degree of toxicity of Gleevec in this cohort of patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed metastatic epithelial ovarian, primary peritoneal cancer, or
             fallopian tube cancer previously treated with a platinum/taxane-containing regimen.
             Patients may have either low-grade or high-grade recurrent epithelial tumors.

          2. Patients with high-grade tumors must be platinum/taxane resistant, as defined by:
             progression of disease while on a first-line platinum/taxane regimen or tumor
             progression within 6 months of completion of a platinum/taxane regimen.

          3. Patients with high-grade tumors may have failed no more than 4 prior chemotherapy
             regimens. All taxane/platinum therapies will be counted as one regimen.

          4. Patients with low-grade tumors may have failed unlimited prior therapies.

          5. Patients' tumor tissue must express one or more of the following biomarkers: c-KIT,
             PDGFR or ABL. Positivity will be defined as 2+ or 3+ on immunohistochemical staining.

          6. All patients must have measurable disease. Measurable disease is defined as lesions
             which can be measured by physical examination or by means of imaging techniques.
             Ascites and pleural effusions are not to be considered measurable disease. An elevated
             serum CA 125 level without associated measurable tumor is not to be considered
             measurable disease.

          7. Patients must have a pretreatment granulocyte count (i.e., segmented neutrophils +
             bands) of > 1,500/Fl, a hemoglobin level of = 9.0 gm/dL and a platelet count of >
             100,000/Fl.

          8. Patients must have adequate renal function as documented by a serum creatinine <2.0
             mg/dL.

          9. Patients must have adequate hepatic function as documented by a serum bilirubin <1.5
             mg/dL, regardless of whether patients have liver involvement secondary to tumor.
             Aspartate transaminase (SGOT) must be < 3* institutional upper limit of normal unless
             the liver is involved with tumor, in which case the aspartate transaminase must be <
             5* institutional upper limit of normal.

         10. Patients must have an estimated life expectancy of 12 weeks or greater.

         11. Zubrod performance status of 0, 1, or 2.

         12. Patients must be older than age 18.

         13. Patients must have signed an approved informed consent.

        Exclusion Criteria:

          1. Patients who have previously received Gleevec.

          2. Patients with any active or uncontrolled infection, including known HIV infection.

          3. Patients with psychiatric disorders that would interfere with consent or follow-up.

          4. Patients with a history of myocardial infarction within the previous six months or
             congestive heart failure requiring therapy.

          5. Patients with a history of prior malignancy except for adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the
             patient has been disease-free for at least five years.

          6. Pregnant or lactating women. Men and women of reproductive potential may not
             participate unless they have agreed to use an effective contraceptive method.

          7. Presence of clinically apparent central nervous system metastases or carcinomatous
             meningitis.

          8. Patients with a history of seizures are ineligible. Patients receiving phenytoin,
             phenobarbital, or other antiepileptic prophylaxis are ineligible.

          9. Patients with any other severe concurrent disease which in the judgment of the
             investigator, would make the patient inappropriate for entry into this study,
             including significant hepatic, renal, or gastrointestinal diseases.

         10. Patients with a deep venous or arterial thrombosis (including pulmonary embolism)
             within 6 weeks of study entry.

         11. Patients who are receiving warfarin.