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

ARCAGY/ GINECO GROUP2 个研究点分布在 1 个国家目标入组 45 人开始时间: 2005年9月19日最近更新: 2007年8月17日

适应症

试验速览

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.

•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

•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

发起方

ARCAGY/ GINECO GROUP

申办方类型

Other

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