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

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: Carboplatin Paclitaxel Trastuzumab

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

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

Sponsors and Collaborators

ARCAGY/ GINECO GROUP

Laboratoire Roche

Investigators

Study Chair:

Eric Pujade-Lauraine, MD, PhD

Hopital Hotel-Dieu

More Information

Study ID Numbers:	TCHERCEPTIN1
Study First Received:	September 12, 2005
Last Updated:	August 16, 2007
ClinicalTrials.gov Identifier:	NCT00189579
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 cancer
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases

Carboplatin
Genital Diseases, Female
Paclitaxel
Trastuzumab
Endocrinopathy
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators

Tubulin Modulators
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009