再発性卵巣癌、上皮癌、原発性腹膜癌、または卵管癌患者における手術後のカルボプラチン、パクリタキセル、およびゲムシタビン塩酸塩（ベバシズマブ併用または非併用）の治療

基本情報

NCT ID: NCT00565851
ステータス: 実施中（募集終了）
試験のフェーズ: 第3相
試験タイプ: 介入
目標被験者数: 1,052
治験依頼者名: National Cancer Institute (NCI)

概要

This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

対象疾患

Clear Cell AdenocarcinomaFallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Mucinous AdenocarcinomaFallopian Tube Serous AdenocarcinomaFallopian Tube Transitional Cell CarcinomaFallopian Tube Undifferentiated CarcinomaMucinous AdenocarcinomaOvarian Brenner TumorOvarian Clear Cell AdenocarcinofibromaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Seromucinous CarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaOvarian Undifferentiated CarcinomaPrimary Peritoneal Clear Cell AdenocarcinomaPrimary Peritoneal Endometrioid AdenocarcinomaPrimary Peritoneal Serous AdenocarcinomaPrimary Peritoneal Transitional Cell CarcinomaPrimary Peritoneal Undifferentiated CarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal CarcinomaUndifferentiated Carcinoma

介入

Bevacizumab(BIOLOGICAL)

Carboplatin(DRUG)

Docetaxel(DRUG)

Gemcitabine Hydrochloride(DRUG)

Laboratory Biomarker Analysis(OTHER)

Paclitaxel(DRUG)

Quality-of-Life Assessment(OTHER)

依頼者（Sponsor）

National Cancer Institute (Nci)(NIH)

Nrg Oncology(OTHER)

実施施設 (16)

東北大学病院

Sendai, Aoba-ku, Japan

独立行政法人国立病院機構　九州がんセンター

Minamiku, Japan

新潟大学医歯学総合病院

Niigata, Niigata, 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

近畿大学病院

Osaka, Japan

Tottori University

Tottori, Japan

Jikei University School of Medicine

Minato-ku, Tokyo, Japan

広島大学病院

Hiroshima, 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

Shiwa-gun, Iwate, Japan

北海道大学病院

Sapporo, Hokkaido, 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

静岡県立静岡がんセンター

Shizuoka, Suntou, Japan