Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II, Phase I | Treatment | Completed | 18 and over | Other | CRC 0503 NCT00316407 |
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.
Further Study Information
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.
Eligibility Criteria
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.
Trial Lead Organizations/Sponsors
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
GlaxoSmithkline| Saul E. Rivkin |  | Principal Investigator |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00316407
Information obtained from ClinicalTrials.gov on November 20, 2012
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