再発性プラチナ製剤耐性卵巣癌におけるセディラニブとオラパリブの併用療法と、各薬剤単独療法または他の化学療法との比較試験

基本情報

NCT ID: NCT02502266
ステータス: 実施中（募集終了）
試験のフェーズ: 第2/第3相
試験タイプ: 介入
目標被験者数: 582
治験依頼者名: National Cancer Institute (NCI)

概要

This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent) after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Chemotherapy drugs 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. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

対象疾患

Fallopian Tube Clear Cell AdenocarcinomaFallopian Tube Endometrioid AdenocarcinomaFallopian Tube Serous AdenocarcinomaFallopian Tube Transitional Cell CarcinomaFallopian Tube Undifferentiated CarcinomaOvarian Clear Cell AdenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Seromucinous CarcinomaOvarian Serous AdenocarcinomaOvarian Transitional Cell CarcinomaOvarian Undifferentiated CarcinomaPrimary Peritoneal Serous AdenocarcinomaRecurrent Fallopian Tube CarcinomaRecurrent Ovarian CarcinomaRecurrent Primary Peritoneal Carcinoma

介入

Magnetic Resonance Imaging(PROCEDURE)

Olaparib(DRUG)

Cediranib(DRUG)

Cediranib Maleate(DRUG)

Computed Tomography(PROCEDURE)

Paclitaxel(DRUG)

Pegylated Liposomal Doxorubicin Hydrochloride(DRUG)

Questionnaire Administration(OTHER)

Topotecan(DRUG)

Topotecan Hydrochloride(DRUG)

依頼者（Sponsor）

National Cancer Institute (Nci)(NIH)

Nrg Oncology(OTHER)

Canadian Cancer Trials Group(NETWORK)

実施施設 (7)

公益財団法人がん研究会　有明病院

Koto-ku, Tokyo, Japan

鹿児島市立病院

Kagoshima, Kagoshima-ken, Japan

近畿大学病院

Osaka, 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

北海道大学病院

Sapporo, Hokkaido, Japan

埼玉医科大学国際医療センター

Saitama, Japan

愛媛大学医学部附属病院

Tōon, Ehime, Japan