Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients
Phase 1
Completed
- Conditions
- Stage IV Breast CancerOvarian Epithelial Cancer Stage IIIStage IV Ovarian Cancer
- Registration Number
- NCT00316407
- Lead Sponsor
- Swedish Medical Center
- Brief Summary
The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.
- Detailed Description
The MTD was found in the phase I portion of this study to be oral lapatinib 1000 mg per day for each 4 week cycle and paclitaxel 60 mg/m2 weekly x 3 of a 4 week cycle and carboplatin AUC 2 weekly x 3 of a 4 week cycle.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
Inclusion Criteria
- Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma patients.
- Stage IV metastatic breast cancer patients who have failed no more than four previous chemotherapies for Stage IV disease.
- Ability to swallow and retain oral medications.
- Measurable disease
Exclusion Criteria
- Treatment with previous weekly carboplatin and paclitaxel.
- No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and cetuximab.
- No concomitant requirement for medication classification as CYP3A4 inducers or inhibitors.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Toxicity 1 year
- Secondary Outcome Measures
Name Time Method Objective response (PR or CR) 1 year
Trial Locations
- Locations (2)
Swedish Medical Center Cancer Institute
🇺🇸Seattle, Washington, United States
University of New Mexico Cancer Center
🇺🇸Albuquerque, New Mexico, United States