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

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 1

Conditions: Ovarian Cancer

Treatments: Drug: lapatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00317434

104239

UAB 0538 - F051025014

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)