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

Phase 1

Terminated

• Conditions: Ovarian Cancer

• Registration Number: NCT00317434
• Lead Sponsor: University of Alabama at Birmingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-04-20
• Study First Submitted QC: 2006-04-20
• Study First Posted: 2006-04-24
• Primary Completion: 2007-03
• Study Completion: 2007-04
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-10
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
MTD of Lapatinib measured in cohorts of 3-6 patients each

Secondary Outcome Measures

Name	Time	Method
Clinical response rate defined by RECIST and CA125 values
EGRF, ErbB-2, PTEN and K-ras expression in tissue samples
Correlate serum levels of Lapatinib with AE's & efficacy

Trial Locations

Locations (2)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States