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

Primary Purpose

Ovarian Cancer

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Herceptin
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring HERCEPTIN, Carboplatin, Paclitaxel, Relapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Hotel-Dieu

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
August 16, 2007
Sponsor
ARCAGY/ GINECO GROUP
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00189579
Brief Title
Addition of Herceptin to a Carboplatin-Paclitaxel Regimen in Patients With Ovarian Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ARCAGY/ GINECO GROUP
Collaborators
Hoffmann-La Roche

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
HERCEPTIN, Carboplatin, Paclitaxel, Relapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Herceptin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Pujade-Lauraine, MD, PhD
Organizational Affiliation
Hopital Hotel-Dieu
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Hotel-Dieu
City
Paris
ZIP/Postal Code
75004
Country
France

12. IPD Sharing Statement

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

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