Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
第3相
実施中(募集終了)
NCT02446600
| 対象疾患 | Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Transitional Cell Carcinoma, Fallopian Tube Undifferentiated Carcinoma, Ovarian Clear Cell Adenocarcinoma |
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| 相 | 第3相 |
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| スポンサー | National Cancer Institute (NCI) |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 579 名 |
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| 介入(薬剤) | Biospecimen Collection, Carboplatin, Cediranib Maleate, Computed Tomography, Echocardiography Test |
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| 開始日 | 2016年3月28日 |
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| 完了日 | 2020年2月23日 |
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| 結果公開日 | 2021年3月12日 |
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概要
This phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin 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. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.
Progression Free Survival Determined Using Response Evaluation Criteria in Solid Tumors Version 1.1 Criteria
The protocol required lesion assessments every 9 weeks from cycle 1, day 1 for the first year, then every 12 weeks thereafter until disease progression. An average of approximately 10 months. · months
| Arm I (Platinum-based Chemotherapy) | 10.3 months |
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| Arm II (Olaparib) | 8.2 months |
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| Arm III (Olaparib, Cediranib Maleate) | 10.4 months |
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| p-value | 0.077 |
| Hazard Ratio (HR) | 0.856 (95% CI 0.663–1.105) |
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