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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00189579
• Date of registration: 12/09/2005
• Prospective Registration: No
• Primary sponsor: ARCAGY/ GINECO GROUP
• Public title: Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer
• Scientific 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
• Date of first enrolment: April 2004
• Target sample size: 45
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00189579
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

France

Contacts

• Name: Eric Pujade-Lauraine, MD, PhD
• Affiliation: Hopital Hotel-Dieu

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Ovarian Cancer

Intervention(s)

Drug: Herceptin

Secondary ID(s)

TCHERCEPTIN1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Hoffmann-La Roche