Phase I/II Lapatinib Plus Carboplatin and Paclitaxel in Stage III or IV Relapsed Ovarian or Stage IV Breast Cancer Patients
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.
- Relapsed (Stage III or IV) ovarian, primary peritoneal, fallopian tube carcinoma
- 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
- Treatment with previous weekly carboplatin and paclitaxel.
- No prior treatment with erbB targeting therapies such as erlotinib, gefitinib and
- No concomitant requirement for medication classification as CYP3A4 inducers or
Type of Study:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Time Frame:
Saul Rivkin, MD
Swedish Medical Center Cancer Institute
United States: Food and Drug Administration
- Ovarian Epithelial Cancer Stage III
- Stage IV Ovarian Cancer
- Stage IV Breast Cancer
- Breast Neoplasms
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
|University of New Mexico Cancer Center
||Albuquerque, New Mexico 87131-5636
|Swedish Medical Center Cancer Institute
||Seattle, Washington 98104