Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer

• Status: Terminated
• Trial end date: 2007-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to evaluate whether or not the addition of Herceptin may be of benefit to a standard regimen of carboplatin-paclitaxel.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCAGY/ GINECO GROUP
• Collaborator: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel; Trastuzumab

Criteria

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