Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Toxicity
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Saul Rivkin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Swedish Medical Center Cancer Institute
Authority:
United States: Food and Drug Administration
Study ID:
CRC 0503
NCT ID:
NCT00316407
Start Date:
August 2005
Completion Date:
November 2009
Related Keywords:
- Ovarian Epithelial Cancer Stage III
- Stage IV Ovarian Cancer
- Stage IV Breast Cancer
- Breast Neoplasms
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
University of New Mexico Cancer Center |
Albuquerque, New Mexico 87131-5636 |
Swedish Medical Center Cancer Institute |
Seattle, Washington 98104 |