Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00317434
Recruitment Status :
(Due to unacceptable non-dose limiting toxicities, excessive treatment delays and limited clinical responses.)
The purpose of this study is to determine the maximum tolerated dose of Lapatinib with Carboplatin AUC 6 in patients with platinum sensitive recurrent ovarian or primary peritoneal carcinoma and to determine the nature and degree of toxicity of Lapatinib in combination with carboplatin AUC 6 in this cohort of patients.
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Ages Eligible for Study:
19 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologic diagnosis of epithelial ovarian or primary peritoneal cancer
Measurable disease or evaluable disease with CA125 >100
One prior treatment with taxane/platinum based chemotherapy, but patients with recurrent ovarian cancer not receiving platinum-based chemotherapy at time of initial diagnosis will be allowed
Recurrence after treatment free interval of at least 6 mos from completion of primary chemotherapy
19 years of age or older
Life expectancy of greater than 12 weeks
Performance status of 0, 1 or 2 (based on GOG Performance Status)
Normal bone marrow, renal and hepatic function based upon lab tests
Cardiac ejection fraction within institutional normal range
Ability to swallow and retain oral medication
Ability to understand a written informed consent document
Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering study
Epithelial ovarian tumors of low malignant potential, stromal or germ cell origin
Non-measurable or non-evaluable disease
Archived tumor tissue not available for assay
Patients may not be receiving any other investigational agents or concurrent anticancer therapy, or herbal (alternative) medicines
Patients with known brain metastases
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.