NCT00552149已完成2 期
A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination With Cetuximab in Patients With Advanced Biliary Cancer.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months
研究概览
简要总结
A Multicenter, Randomized Phase II Trial Assessing the Activity of Gemcitabine - Oxaliplatin Chemotherapy Alone or in Combination with Cetuximab in Patients with Advanced Biliary Cancer.
详细描述
The BINGO trial is an open-label randomized phase II study evaluating the efficacy and tolerance of gemcitabine-oxaliplatin combination chemotherapy (GEMOX regimen) alone or in combination with cetuximab in patients (pts) with ABC. The BINGO study also comprises ancillary translational research and functional imaging studies which aim to identify markers predictive for treatment efficacy in ABC.
All eligible pts will be randomized 1:1 to receive:
- Arm A: GEMOX alone every two weeks.
- Arm B: GEMOX + cetuximab every two weeks.
Randomization will be stratified according to:
- tumor stage (locally advanced vs metastatic),
- primary tumor location (gallbladder vs non-gallbladder),
- prior treatments (surgery or radiotherapy or brachytherapy or photodynamic therapy [PDT] or adjuvant chemotherapy vs none),
- center. EGFR tumor status has to be assessed for every pt by immunohistochemistry (IHC) using biopsy or surgical material, at any time prior to inclusion into the study, but it is neither an inclusion/exclusion criterion nor a stratification factor.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the biliary tract (gallbladder, intra and/or extrahepatic bile ducts, or ampulla of Vater):
- •Cytologically or histologically confirmed. In case of uncertain biliary tract origin (e.g., intrahepatic, peripheral cholangiocarcinomas), inclusion is possible if i) extensive search for primary (thoracic and abdominopelvic CT scan, colonoscopy, upper digestive endoscopy, serum PSA level for men or mammography for women, and FDG-PET if possible) is negative; and ii) histological examination is consistent with bile duct adenocarcinoma (IHC should ideally be performed and be consistent with biliary primary, e.g., positive for cytokeratin 7 and 19 and negative for cytokeratin 20).
- •not amenable to curative resection, or recurrent after resection (i.e., locally advanced or metastatic),
- •With at least one unidimensionally measurable target lesion in a non-irradiated, non-PDT-treated area (longest diameter 1 cm [spiral CT scan]), or 2 cm [conventional CT scan]).
- •With biliary obstruction controlled,
- •Age between 18 and 75 years.
- •World Health Organization (WHO) performance status of 0 or
- •Life expectancy higher than 3 months.
- •No prior chemotherapy for advanced disease. Previous adjuvant chemotherapy is allowed (completed at least 6 months previously, if containing gemcitabine or platinum salts). Previous irradiation (external radiotherapy, brachytherapy) and PDT are allowed provided that there is at least one unidimensionally measurable target lesion in untreated area.
- •Bilirubin 3 times the upper limit of the normal range (ULN). Pts with jaundice or evidence of bile duct obstruction, in whom the biliary tree can be decompressed by endoscopic or percutaneous endoprothesis with subsequent reduction in bilirubin £ 3 ULN, will be eligible for the study.
- •Aminotransferases (AST, ALT) 5 ULN, INR < 1.5 (following vitamin K1 injection in patients with current or recent history of jaundice or bile duct obstruction), creatinine 1.5 ULN, neutrophils 1.5 109/L, platelets 100 109/L, hemoglobin 9 g/dL (red blood cell transfusion if needed is allowed).
- •Written informed consent. Note: EGFR tumor status has to be known for every pt, but it is neither an inclusion/exclusion criterion nor a stratification factor. EGFR expression has to be assessed by IHC using biopsy or surgical material, at any time prior to inclusion into the study.
排除标准
- •Known central nervous system metastases.
- •Contraindication or history of grade 3-4 allergy reaction to one treatment component.
- •Surgery (except diagnostic biopsy), external radiotherapy, brachytherapy, or PDT within 30 days prior to start of treatment. Prior adjuvant chemotherapy is only allowed if completed at least 30 days previously (6 months if containing gemcitabine or platinum salts).
- •Participation in another clinical trial within 30 days prior to start of treatment.
- •Concomitant systemic chronic immunotherapy, chemotherapy, or antitumor hormone therapy.
- •Previous administration of EGFR inhibitors or EGF.
- •Active uncontrolled infection, peripheral neuropathy grade 2, acute or subacute bowel obstruction or history of inflammatory bowel disease, symptomatic coronary disease or myocardial infarction in the past 6 months, congestive heart failure (NYHA class II), interstitial pneumonitis or respiratory failure, or renal failure.
- •Pregnancy (or positive b-HCG dosage at baseline), breast-feeding, or lack of effective contraception in male or female pts of reproductive potential.
- •Other malignancies either currently active or in the last 5 years, except adequately treated in situ carcinoma of the cervix and basal or squamous cell skin carcinoma.
- •Legal incapacity or physical, psychological or mental status interfering with the pt's ability to terminate the study or to sign the informed consent.
研究组 & 干预措施
1
Active Comparator
GEMOX
干预措施: Gemox, Cetuximab (Drug)
2
Experimental
GEMOX + CETUXIMAB
干预措施: Gemox, Cetuximab (Drug)
结局指标
主要结局
Evaluation of treatment efficacy by assessing the crude progression-free survival (PFS) rate at 4 months
时间窗: 4 months
次要结局
- Evaluation of feasibility and toxicity of the treatments(one year)
- Evaluation of rate and duration of objective tumor response(one year)
- Evaluation of rate and duration of tumor control (objective responses and stabilizations)(one year)
- Evaluation of PFS and over(one year)
研究者
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
1 期
Fase II trial with gemcitabine and oxaliplatin in patients with unknown primary tumours - UPT - unfitTo test the effect of Gemcitabine and axaliplatin in patients with unknown primary tumours and performance 2 or age 66 to 75EUCTR2005-001959-38-DKGedske Daugaard39
已完成
2 期
Clinical Studies of Gemcitabine-OxaliplatinCentral Nervous System TumorsOsteosarcomaMedulloblastomaNeuroblastomaNCT00407433Gustave Roussy, Cancer Campus, Grand Paris156
终止
2 期
A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast CancerBreast CancerNCT00674206Emory University6
已完成
2 期
Gemcitabine With Oxaliplatin (GEMOX) in Patients With Advanced Hepatocellular Carcinoma After Failure of Sorafenib TreatmentHepatocellular Carcinoma, Unresectable, AdvancedNCT05517239Yonsei University32
终止
2 期
Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast CancerRecurrent Breast CancerMetastastic Breast CancerNCT00159458University of Southern California7