Overview

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