Maximum Tolerated Dose of Lapatinib When Given With Carboplatin for Recurrent Ovarian Cancer

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Collaborator: GlaxoSmithKline
• Treatments: Carboplatin; Lapatinib

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Uncontrolled inter-current illness

• Patients who are pregnant

• HIV-positive patients receiving combination anti-retroviral therapy

• Patients with GI tract disease resulting in an inability to take oral medication