INCLUSION CRITERIA:
All patients must have biopsy-proven, epithelial ovarian cancer, relapsed and/or refractory to platinum and taxane-based chemotherapy. Patients with fallopian tube and/or primary peritoneal cancer, or low malignant potential tumor with invasive recurrence will also be eligible. For a first relapse, patients with a disease free interval greater than 12 months may be enrolled only after full informed consent outlining alternative treatment is obtained.
Histopathologic diagnosis must be confirmed in the LP, National Cancer Institute and confirmation is necessary prior to entry. A block or unstained re-cuts of the primary tumor or a recent resection specimen is required for entry.
All patients must have measurable disease to be eligible. All patients must have a sentinel lesion adequate for core biopsy either through percutaneous biopsy or simple laparoscopic means. The lesion must not be in a prior radiation field.
Patients must have a performance status: ECOG = 0, 1 or 2.
Patients must have good end organ function: WBC greater than or equal to 3000/mm(3), ANC greater than 1500/mm(3), hemoglobin greater than or equal to 9.0 (independent of erythropoietin or transfusion), platelets greater than or equal to 100,000/mm(3), normal acute care panel with serum creatinine less than or equal to 1.5 mg/dl, transaminases less than or equal to 2.5 times the upper limit of normal and bilirubin less than or equal to 1.5 mg/dl.
Patients must be at least 4 weeks from prior therapy (chemotherapy, hormonal therapy, signal transduction therapy and radiation therapy). Mitomycin and carboplatin must have been stopped at least 6 weeks prior to enrollment. No concomitant use of alternative, complementary therapies or over the counter agents will be allowed without approval of the PI. Every effort will be made to maximize patient safety and minimize changes in chronic medications. Medications that may alter metabolism of imatinib mesylate and lead to potential toxicity will be allowed at the discretion of the PI.
Number of prior regimens is restricted to four given the risk of marrow toxicity with imatinib mesylate.
All patients must have recovered from prior toxicity to NCI/CTEP grade 1 or better. Patients with residual, stable grade 2 peripheral neuropathy may be enrolled at the discretion of the PI.
Imatinib mesylate causes abortions and is potentially teratogenic at high doses in rabbits and rats. The compound is therefore not suitable for administration to pregnant women, and conception while on therapy should be avoided. In women of childbearing potential, contraception should continue for 3 months after the last dose of imatinib mesylate to allow the complete clearance of drug and its principal metabolites from the body. Since interactions with the metabolism of oral contraceptives cannot be excluded at present, a barrier method of contraception must be used. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with imatinib mesylate, breastfeeding should be discontinued if the mother is treated with imatinib mesylate.
Patients must be able to give written informed consent.
All patients must be registered by calling the ORKAND Corporation at 301-402-1732 between the hours of 8:30 AM and 5:00 PM EST.
EXCLUSION CRITERIA:
Clinical evidence of CNS involvement (abnormal clinical exam) will require a head CT with contrast or MRI).
Patients receiving ketoconazole, itraconazole, erythromycin, or clarithromycin will be excluded unless an alternative drug can be prescribed. Patients on therapeutic doses of warfarin will be excluded due to potential drug interactions with imatinib mesylate and increased risk of serious hemorrhage. These patients may be included if they can be safely converted over to low molecular weight heparin.
History of myocardial infarction or unstable dysrhythmia within six months of study entry. Patients in congestive heart failure will be excluded given a greater risk of fluid retention with imatinib mesylate. This includes patients who may be compensated with furosemide.
History of another invasive malignancy within the last five years. Noninvasive, non-melanoma skin cancers will be allowed.
Patients with active infection will not be eligible, but may be reconsidered once the infection has resolved. Patients must be at least 7 days from completion of antibiotics.
HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with imatinib mesylate or other agents administered during the study.