Phase II, Open-label, Randomized Clinical Trial of Panitumumab Plus Gemcitabine and Oxaliplatin (GEMOX) Versus GEMOX Alone as First Line Treatment in Advanced Biliary Tract Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 12
- 主要终点
- Progression-free survival
研究概览
简要总结
This is a multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).The ame of the Stuy is to evaluate the clinical activity of the P-GEMOX (Panitumumab and GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type)and To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy.
详细描述
Study Phase: Phase II, Open-label, Randomized
Indication: First line treatment in advanced intrahepatic cholangiocarcinoma and extrahepatic biliary adenocarcinoma including gallbladder.
Primary Objective: To evaluate the clinical activity of the Panitumumab and GEMOX (P-GEMOX) combination compared to GEMOX alone in patients with previously untreated surgically unresectable or metastatic biliary tract carcinoma (KRAS wild-type).
Secondary Objectives: To evaluate the safety profile of the P-GEMOX combination; to assess the objective response rate; to assess overall survival; to study the correlation between biomarkers with activity and efficacy.
Study Design: Multi-centre phase II, open-label, randomized (1:1), parallel-arm, study of panitumumab in combination with chemotherapy (P-GEMOX) versus chemotherapy alone (GEMOX). Eligible subjects will be enrolled and randomized to receive first-line combination therapy consisting of panitumumab and GEMOX (experimental arm) or GEMOX alone (control arm).
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
- •Histologically or cytologically documented surgically unresectable or metastatic biliary tract adenocarcinoma (KRAS wild-type) including gallbladder either at diagnosis or relapsing after surgery.
- •Documented KRAS status either on primary tumor or metastasis. KRAS testing will be performed as per center procedure (no centralized analysis is required).
- •Availability of a tumor biopsy for the study of tumor biomarkers potentially involved in the response/resistance mechanisms.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2
- •Estimated life expectancy of at least 3 months.
- •Adequate bone marrow, hepatic, and renal function determined within 2 weeks prior to starting therapy, defined as:
- •absolute neutrophil count (ANC) ≥ 1.5 x 10E9 cells/L
- •platelet count ≥ 100 x 10E9 cells/L
- •total hemoglobin > 9.0 g/dL
- •total bilirubin < 2.0 x institutional upper limit of normal (ULN)
- •alanine aminotransferase (ALT), aspartate transaminase (AST) < 2.5 x ULN - alkaline phosphatase < 3.0 x ULN
- •creatinine < 1.5 X ULN
- •magnesium ≥ LLN
- •calcium ≥ LLN
- •Voluntary, written and dated informed consent.
排除标准
- •Any previous chemotherapy or target therapy .
- •Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
- •Coexisting malignancies, except for basal or squamous cell carcinoma of the skin or other solid tumors curatively treated with no evidence of disease for ≥ 3 years.
研究组 & 干预措施
Arm A- p-Gemox
Panitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once Q2W.
GEMOX chemotherapy will be administered after the administration of panitumumab once Q2W.
Gemcitabine 1000mg/sqm will be administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.
干预措施: Panitumumab plus GEMOX chemotherapy (Drug)
Arm A- p-Gemox
Panitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once Q2W.
GEMOX chemotherapy will be administered after the administration of panitumumab once Q2W.
Gemcitabine 1000mg/sqm will be administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.
干预措施: GEMOX chemotherapy (Drug)
Arm B-GEMOX
Gemcitabine 1000mg/sqm will be administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.
干预措施: GEMOX chemotherapy (Drug)
结局指标
主要结局
Progression-free survival
时间窗: Every 8±1 Weeks until PD
Progression-free survival (PFS), defined as the time from randomization to evidence of progression (RECIST, vers.1.1), death, or last radiographic assessment in absence of a PFS event.
次要结局
- Objective response rate(Every 8±1 Weeks)
- Overall survival(months from randomization to death)
- safety(from the first study drug administration to 28+/-7 days after the last administration)
研究者
Prof. Massimo Aglietta
Professor
Fondazione del Piemonte per l'Oncologia