Cisplatin and Etoposide Versus Temozolomide and Capecitabine in Patients With Advanced Poorly Differentiated (G3) Non-Small Cell Gastrointestinal Neuroendocrine Carcinomas
第2相
実施中(募集終了)
NCT02595424
| 対象疾患 | Gastric Neuroendocrine Carcinoma, Intestinal Neuroendocrine Carcinoma, Pancreatic Neuroendocrine Carcinoma |
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| 相 | 第2相 |
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| スポンサー | ECOG-ACRIN Cancer Research Group |
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| ステータス | 実施中(募集終了) |
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| 参加者数 | 67 名 |
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| 介入(薬剤) | Capecitabine, Carboplatin, Cisplatin, Etoposide, Laboratory Biomarker Analysis |
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| 開始日 | 2015年11月6日 |
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| 完了日 | 2025年4月23日 |
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| 結果公開日 | 2026年4月8日 |
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概要
This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin or carboplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, carboplatin and etoposide, 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. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin or carboplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma.
Progression-free Survival (PFS)
assessed at baseline, every 8 weeks until treatment completion, then every 3 months within 2 years and every 6 months within 3-5 years from randomization until disease progression, up to 5 years from study registration · months
| Arm A (Capecitabine, Temozolomide) | 3.1 months |
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| Arm B (Cisplatin, Carboplatin, Etoposide) | 5.5 months |
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