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

NCT ID: NCT00189579

Last Updated: 2007-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Herceptin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

Hoffmann-La Roche

INDUSTRY

Sponsor Role collaborator

Principal Investigators

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Eric Pujade-Lauraine, MD, PhD

Role: STUDY_CHAIR

Hopital Hotel-Dieu

Locations

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Hopital Hotel-Dieu

Paris, , France

Site Status

Countries

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France

Other Identifiers

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TCHERCEPTIN1

Identifier Type: -

Identifier Source: org_study_id