A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
研究概览
简要总结
The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.
详细描述
Gemcitabine (G) given until progressive disease (PD) is still standard therapy in patients with advanced pancreatic cancer. No standard secondline regimen is available after PD. Best supportive care (BSC) is the main option for these patients. Our phase II study (Pelzer et al, ASCO 2002) showed activity of the OFF (Oxaliplatin/Folinic Acid/5-FU) regimen. To confirm these data we started this multicenter phase III study to examine OFF vs. BSC alone.
165 patients were needed for this study. Following CT/ MRT confirmed PD patients were randomized. Stratification included duration of firstline therapy, Karnofsky Performance Status (KPS) and tumor stage. OFF (outpatient regimen): 5-FU 2g/m² (24h)/FA 200 mg/m² (30min) on d1, d8, d15, d22, additional Oxaliplatin 85mg/m² (2h) on day 8 and 22. Rest on day 23 and 42.
研究设计
- 研究类型
- Expanded Access
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
- •Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that had progressed during first line gemcitabine therapy were eligible for inclusion in the study.
- •Other inclusion criteria were:
- •Age > 18 years
- •Karnofsky performance status > 70%
- •Bidimensionally measurable reference lesion, adequate laboratory values for hematology (white blood cell [WBC] count > 3.5´109/L, platelet count > 100´109/L), renal function (creatine clearance > 30 ml/min) and hepatic function (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] < 2.5 ´ upper normal limit [UNL] and in the case of liver metastasis < 5 x UNL)
- •As well as controlled pain
排除标准
- •Patients were excluded from the study if they had any severe concurrent medical condition interfering with planned therapy, serious cardiac disease, sensory/ motor neuropathy > grade 2 or had previous or current malignancies at other origin; besides, pregnant or lactating women were excluded.
- •All patients provided written informed consent.