Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer
Phase 2
Terminated
- Conditions
- Ovarian Cancer
- Registration Number
- NCT00189579
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 45
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hopital Hotel-Dieu
🇫🇷Paris, France