A Phase I Trial of Lapatinib in Combination With Carboplatin in Patients With Platinum Sensitive Recurrent Epithelial Ovarian Cancer

University of Alabama at Birmingham2 sites in 1 country12 target enrollmentNovember 2005

ConditionsOvarian Cancer

Drugslapatinib

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Ovarian Cancer
Sponsor: University of Alabama at Birmingham
Enrollment: 12
Locations: 2
Primary Endpoint: MTD of Lapatinib measured in cohorts of 3-6 patients each
Status: Terminated
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2005

End Date

April 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Alabama at Birmingham

Eligibility 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

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