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

This study has been terminated.

First Received: September 12, 2005 Last Updated: August 16, 2007 History of Changes

Sponsors and Collaborators:	ARCAGY/ GINECO GROUP Laboratoire Roche
Information provided by:	ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:	NCT00189579

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 II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Paclitaxel Carboplatin Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
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

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

Laboratoire Roche

Investigators

Study Chair:

Eric Pujade-Lauraine, MD, PhD

Hopital Hotel-Dieu

More Information

No publications provided

Study ID Numbers:	TCHERCEPTIN1
Study First Received:	September 12, 2005
Last Updated:	August 16, 2007
ClinicalTrials.gov Identifier:	NCT00189579 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by ARCAGY/ GINECO GROUP:

HERCEPTIN
Carboplatin
Paclitaxel
Relapse

Study placed in the following topic categories:

Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Carboplatin

Genital Diseases, Female
Paclitaxel
Tubulin Modulators
Trastuzumab
Ovarian Cancer
Endocrinopathy
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Ovarian Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Antimitotic Agents
Ovarian Diseases
Carboplatin

Pharmacologic Actions
Adnexal Diseases
Genital Diseases, Female
Neoplasms
Neoplasms by Site
Paclitaxel
Therapeutic Uses
Tubulin Modulators
Trastuzumab
Antineoplastic Agents, Phytogenic
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009