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

Swedish Medical Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Ovarian Epithelial Cancer Stage III

Stage IV Ovarian Cancer

Stage IV Breast Cancer

Treatments

Drug: lapatinib (GW572016)

Drug: Paclitaxel

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00316407

CRC 0503

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness, safety, tolerability and best dose of Lapatinib (GW572016) in combination with carboplatin and paclitaxel.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.