NCT00602082已完成2 期
A Randomised Phase II Study Comparing Capecitabine Plus Streptozocin With or Without Cisplatin Chemotherapy as Treatment for Unresectable or Metastatic Neuroendocrine Tumors
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 17
- 主要终点
- Objective response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as capecitabine, streptozocin, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving capecitabine together with streptozocin is more effective with or without cisplatin in treating neuroendocrine tumors.
PURPOSE: This randomized phase II trial is studying giving capecitabine together with streptozocin to see how well it works compared with or without cisplatin in treating patients with unresectable or metastatic neuroendocrine tumors.
详细描述
OBJECTIVES:
Primary
- To determine the objective response rate in patients with neuroendocrine tumors treated with capecitabine and streptozocin with or without cisplatin.
Secondary
- To determine the overall response rate, including both objective and biochemical responses, to these regimens.
- To determine the functional response to these regimens.
- To determine the toxicity of these regimens.
- To identify the optimal drug doses in each regimen to be recommended for a subsequent phase III trial.
- To determine the progression-free and overall survival of patients receiving these regimens.
- To determine the quality of life of these patients.
- To determine molecular markers predictive of response to chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed unresectable, advanced, and/or metastatic disease meeting one of the following types:
- •Gastroentero-neuroendocrine tumor of the foregut
- •Pancreatic neuroendocrine tumor
- •Neuroendocrine tumor of unknown primary
- •Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (the longest diameter) ≥ 20 mm by conventional CT scanning or ≥ 10 mm by spiral CT scan or MRI
- •No bronchial neuroendocrine tumors (NETs) or other NETs where the primary site is situated in organs above the diaphragm (e.g., laryngeal and pharyngeal NETs)
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 10 g/dL
- •Platelet count ≥ 100,000/mm³
- •WBC ≥ 3,000/mm³
- •ANC ≥ 1,500/mm³
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 5 times ULN
- •AST and ALT ≤ 5 times ULN
- •GFR ≥ 60 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
- •No other serious or uncontrolled illness that would preclude study participation
- •No medical or psychiatric condition that would influence the ability to provide consent
- •PRIOR CONCURRENT THERAPY:
- •At least 3 weeks since prior interferon therapy
- •No prior systemic chemotherapy or chemotherapy administered as part of a chemo-embolization regimen, or for this condition
- •No receptor-targeted radiolabeled therapy within the past 6 months
- •No investigational agent within the past 4 weeks
- •Prior and concurrent somatostatin analogues allowed provided symptoms are no longer controlled by this treatment or there is documented measurable disease progression on serial CT scans performed up to 6 months apart
- •No palliative radiotherapy involving lesions used to measure disease
- •Palliative radiotherapy to regions not involved in measurement of disease allowed
- •No other concurrent chemotherapy for this condition
排除标准
- 未提供
结局指标
主要结局
Objective response rate
次要结局
- Overall response rate
- Functional response
- Toxicity
- Progression-free survival
- Overall survival
- Molecular markers predictive of response to chemotherapy
- Quality of life
研究者
研究点 (17)
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