Status:
TERMINATED
Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer
Lead Sponsor:
ARCAGY/ GINECO GROUP
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2007
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00189579
End Date
January 1 2007
Last Update
August 17 2007
Active Locations (1)
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1
Hopital Hotel-Dieu
Paris, France, 75004