Ovarian Epithelial Cancer Stage III, Stage IV Breast Cancer, Stage IV Ovarian Cancer
Conditions
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.
Interventions
1000 mg po qd
DRUGCarboplatin
AUC 2 weekly x 3 of 4 week cycle
DRUGPaclitaxel
60 mg/m2 weekly x 3 of 4 week cycle
Sponsors
GlaxoSmithKline
Swedish Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Objective response (PR or CR) | 1 year |
Countries
United States
Outcome results
None listed