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

ARCAGY/ GINECO GROUP

Status and phase

Terminated

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Herceptin

Study type

Interventional

Funder types

Other

Industry

Identifiers

TCHERCEPTIN1

Details and patient eligibility

About

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.

Enrollment

45 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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