A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel
Inclusion Criteria:
- 18 years or older; patients with histologically proven diagnosis of ovarian cancer.
- Patients with metastatic disease and an overexpression of HER2 (as determined by
immunochemistry)
- Patients who have progressed while receiving treatment, or within 6 months after
completion of treatment. Patients must have received carboplatin and paclitaxel.
- Patients who have received at minimum one line of chemotherapy
- 3 weeks minimum since last treatment with chemotherapy must have elapsed
- Patients must have at least 1 measurable lesion per Response Evaluation Criteria in
Solid Tumors (RECIST) or an assessable cancer antigen (CA) 125 > 1.25 x upper limit
of normal (ULN)
- Patients must have ECOG of 2 or less
- Left ventricular ejection fraction (LVEF) of 50% or better
- Patients have given their signed and verbal consent
Exclusion Criteria:
- Previous treatment with Herceptin or similar products affected growth factors (eg:
Iressa)
- Another experimental treatment in the previous 30 days
- No overexpression of HER2 receptors
- Patients having received high-dose chemotherapy or stem-cell interventions
- Other cancers within the last 5 years
- Patients with dyspnea at rest or requiring oxygen therapy