This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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: None (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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by ARCAGY/ GINECO GROUP:

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 22, 2017