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

This study has been terminated.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00189579
First received: September 12, 2005
Last updated: August 16, 2007
Last verified: August 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

Estimated Enrollment: 45
Study Completion Date: January 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189579

Locations
France
Hopital Hotel-Dieu
Paris, France, 75004
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Hoffmann-La Roche
Investigators
Study Chair: Eric Pujade-Lauraine, MD, PhD Hopital Hotel-Dieu
  More Information

No publications provided

ClinicalTrials.gov 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:
HERCEPTIN
Carboplatin
Paclitaxel
Relapse

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
 Trastuzumab
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 23, 2013