Ovarian Cancer
Conditions
Keywords
HERCEPTIN, Carboplatin, Paclitaxel, Relapse
Brief 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.
Interventions
DRUGHerceptin
Sponsors
Hoffmann-La Roche
ARCAGY/ GINECO GROUP
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
France
Outcome results
None listed