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

This study has been terminated.
Hoffmann-La Roche
Information provided by:
First received: September 12, 2005
Last updated: August 16, 2007
Last verified: August 2007
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.

Condition Intervention Phase
Ovarian Cancer
Drug: Herceptin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by ARCAGY/ GINECO GROUP:

Estimated Enrollment: 45
Study Completion Date: January 2007

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00189579

Hopital Hotel-Dieu
Paris, France, 75004
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Eric Pujade-Lauraine, MD, PhD Hopital Hotel-Dieu
  More Information Identifier: NCT00189579     History of Changes
Other Study ID Numbers: TCHERCEPTIN1 
Study First Received: September 12, 2005
Last Updated: August 16, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by ARCAGY/ GINECO GROUP:

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators processed this record on April 27, 2016