ステージIIIまたはステージIVの卵巣上皮癌、原発性腹膜癌、または卵管癌患者に対するカルボプラチンとパクリタキセルの併用療法（ベバシズマブ併用または非併用）

基本情報

NCT ID: NCT00262847
ステータス: 完了
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 1,873
治験依頼者名: National Cancer Institute (NCI)

概要

This randomized phase III trial studies carboplatin, paclitaxel, and bevacizumab to see how well they work compared to carboplatin, paclitaxel, and placebo in treating patients with stage III or stage IV ovarian epithelial, primary peritoneal, or fallopian tube cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether carboplatin, paclitaxel, and bevacizumab are more effective than carboplatin, paclitaxel, and placebo in treating ovarian epithelial, primary peritoneal, or fallopian tube cancer.

対象疾患

Fallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Mucinous AdenocarcinomaFallopian Tube Serous AdenocarcinomaFallopian Tube Transitional Cell CarcinomaMalignant Ovarian Mixed Epithelial TumorOvarian Brenner TumorOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mucinous AdenocarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaPrimary Peritoneal Serous AdenocarcinomaStage IIIA Fallopian Tube CancerStage IIIA Ovarian CancerStage IIIA Primary Peritoneal CancerStage IIIB Fallopian Tube CancerStage IIIB Ovarian CancerStage IIIB Primary Peritoneal CancerStage IIIC Fallopian Tube CancerStage IIIC Ovarian CancerStage IIIC Primary Peritoneal CancerStage IV Fallopian Tube CancerStage IV Ovarian CancerStage IV Primary Peritoneal CancerUndifferentiated Fallopian Tube CarcinomaUndifferentiated Ovarian Carcinoma

介入

Bevacizumab(BIOLOGICAL)

Carboplatin(DRUG)

Laboratory Biomarker Analysis(OTHER)

Paclitaxel(DRUG)

Placebo(OTHER)

Quality-of-Life Assessment(OTHER)

依頼者（Sponsor）

Nrg Oncology(OTHER)

National Cancer Institute (Nci)(NIH)

実施施設 (10)

東北大学病院

Sendai, Aoba-ku, Japan

独立行政法人国立病院機構神戸医療センター

Kobe, Japan

独立行政法人国立病院機構四国がんセンター

Matsuyama, Japan

鹿児島市立病院

Kagoshima, Kagoshima-ken, Japan

慶應義塾大学病院

Shinjuku-ku, Tokyo, Japan

国立研究開発法人国立がん研究センター中央病院

Tokyo, Japan

岩手医科大学附属病院

Morioka, Iwate, Japan

社会福祉法人恩賜財団済生会支部　広島県済生会　済生会呉病院

Kure, Hiroshima, Japan

埼玉医科大学国際医療センター

Saitama, Japan

Tottori University

Tottori, Japan