A Prospective, Randomized Trial Of Simultaneous Pancreatic Cancer Treatment With Enoxaparin and ChemoTherapy (PROSPECT)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- DVT/TVE event rate
研究概览
简要总结
To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm.
N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%
详细描述
Approximately 20% of patients (pts) diagnosed with pancreatic adenocarcinoma (PA) develop venous thromboembolism, which may contribute to the dismal prognosis of PA. A small phase II trial suggested an improved survival by the addition of low molecular weight heparin (LMWH) to chemotherapy. We conducted a small pilot study which indicated that the addition of enoxaparin to chemotherapy GFFC chemotherapy is safe and feasible in pts with advanced PA. Furthermore, results of several phase III studies suggest that pts in good performance status may benefit from more intensive chemotherapy regimen (Riess et al; Heinemann et al; ASCO 2005). Based on these considerations we started the multicenter phase III study CONKO 004.
540 patients are to be recruited into this study. Primary stratification takes place according to Karnofsky performance status and kidney function. Patients with KPS > 80% and normal kidney function receive GFFC +/- LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with KPS < 80 % and increased creatinin plasma levels (>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) +/- LMWM +/- Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) +/- Enoxaparin 40mg/d s.c.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •histological or cytological pancreatic carcinoma, stage IV A, b
- •no preceding radio or chemotherapy of the primarius or the reference lesions
- •Karnofsky performance status ≥ 60%
- •measurable tumor lesion by spiral CT or MRT not older than 14 days
- •no deep venous thrombosis within the last 2 years
- •patient compliance and geographical proximity of the residence, which make an adequate follow up possible
- •sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l
- •signed informed consent
- •minimum age of 18 years
- •women/men must provide sufficient pregnancy prevention
排除标准
- •preexisting indication for anti-coagulation of other reason
- •bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks)
- •body weight < 45 kg and/or > 100 kg
- •pregnancy or insufficient preventing methods in the study process
- •serious illness, which are incompatible with a study participation
- •hypersensitivity to study drugs
- •patients with serious kidney malfunction (Creatininclearance < 30 ml/min)
研究组 & 干预措施
A
Patients with KPS > 80% and normal kidney function receive GFFC + LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.).
Pts with KPS < 80 % and increased creatinin plasma levels (>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) + Enoxaparin 1mg/kg daily s.c.
After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) + Enoxaparin 40mg/d s.c.
干预措施: enoxaparin (Drug)
A
Patients with KPS > 80% and normal kidney function receive GFFC + LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.).
Pts with KPS < 80 % and increased creatinin plasma levels (>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) + Enoxaparin 1mg/kg daily s.c.
After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) + Enoxaparin 40mg/d s.c.
干预措施: chemotherapy with LMWH - enoxaparin (Drug)
B
Patients with KPS > 80% and normal kidney function receive GFFC - LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w - Enoxaparin 1mg/kg daily s.c.).
Pts with KPS < 80 % and increased creatinin plasma levels (>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) - Enoxaparin 1mg/kg daily s.c.
After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) - Enoxaparin 40mg/d s.c.
干预措施: only chemotherapy (Drug)
结局指标
主要结局
DVT/TVE event rate
时间窗: After 12 events and after 24 events or after 540 pts recruited
次要结局
- TTP, OS, side effects(after 12 events and after 24 events or after 540 pts are recruited)
研究者
Uwe Pelzer MD
Dr. med. Uwe Pelzer
CONKO-Studiengruppe