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

Ovarian Cancer Clinical Trial

Official title:

A Phase II Study Designed to Evaluate the Safety and Efficacy of the Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Early Relapse Patients (< 6 Months) With Ovarian Cancer, Overexpressing HER2, Previously Treated With Carboplatin-Paclitaxel

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00189579
• Other study ID #: TCHERCEPTIN1
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 16, 2007
• Est. completion date: January 2007

Study information

• Verified date: August 2007
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Herceptin

Locations

Country	Name	City	State
France	Hopital Hotel-Dieu	Paris

Sponsors (2)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	Hoffmann-La Roche

Country where clinical trial is conducted

France,