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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00189579
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : August 17, 2007
Hoffmann-La Roche
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Brief 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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Herceptin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
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
Actual Study Completion Date : January 2007

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00189579

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Hopital Hotel-Dieu
Paris, France, 75004
Sponsors and Collaborators
Hoffmann-La Roche
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Study Chair: Eric Pujade-Lauraine, MD, PhD Hopital Hotel-Dieu

Layout table for additonal information Identifier: NCT00189579     History of Changes
Other Study ID Numbers: TCHERCEPTIN1
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: August 17, 2007
Last Verified: August 2007

Keywords provided by ARCAGY/ GINECO GROUP:

Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological