NCT00316407

Lapatinib/Carboplatin/Paclitaxel in Previously Treated Ovarian or Breast Cancer Patients

Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Swedish Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Epithelial Cancer Stage III
• Stage IV Ovarian Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	lapatinib (GW572016)	1000 mg po qd
DRUG	Carboplatin	AUC 2 weekly x 3 of 4 week cycle
DRUG	Paclitaxel	60 mg/m2 weekly x 3 of 4 week cycle

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2006-04-20
• Last updated: 2011-02-18

Locations

2 sites across 1 country: United States