NCT00513266Unknown2 期
Oxaliplatin-CPT-11-5-FU-Leucovarin + Bevacizumab and Cetuximab (OCFL-BC) as a Combination Regimen for Systemic Treatment of Advanced Colorectal Carcinoma With Potentially Resectable Liver and/or Lung Metastases. A Phase II Study
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, irinotecan, fluorouracil and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving combination chemotherapy together with monoclonal antibody therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with monoclonal antibody therapy works in treating patients with advanced colorectal cancer with liver metastases or lung metastases that are potentially removable by surgery.
详细描述
OBJECTIVES:
Primary
- To determine the pathological complete response (CR) rate in resected patients assessed on lesions of less than or equal to 30 mm in size.
Secondary
- To determine the clinical CR rate in all patients.
- To determine toxicity and tolerability of this regimen (pre- and postoperative toxicity).
- To evaluate perioperative safety in these patients.
- To determine disease-free survival (time to progression in unresected patients) and overall survival of the whole study population.
- To determine resectability in these patients.
- To evaluate markers that predict the occurrence of a pathological CR or a non-response in pathological material (resected liver metastasis) and biological material collected from these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Histologically confirmed metastatic colorectal adenocarcinoma
- •Bidimensionally measurable metastatic disease limited to the liver and considered curatively resectable after response to systemic therapy as assessed by a surgical board
- •Additional metastatic disease to the lungs consisting of no more than 3 potentially resectable lesions allowed
- •Must have at least one lesion of 30 mm or less
排除标准
- •History or evidence upon physical examination of CNS disease unless adequately treated (e.g., uncontrolled seizure with standard medical therapy or history of stroke)
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •Performance status ≤ 1
- •Life expectancy > 12 weeks
- •WBC ≥ 3,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Creatinine 1.25 x upper limit of normal (ULN)
- •Bilirubin 1.25 x ULN (1.5 x ULN if liver metastasis)
- •AST and ALT ≤ 3 x ULN (≤ 5 x ULN if liver metastasis)
- •Woman and men of childbearing age must use adequate contraception
- •Exclusion criteria:
- •Pregnancy (positive serum pregnancy test) or lactation
- •Chronic diarrhea ≥ grade 2
- •Other serious illness or medical condition including any of the following:
- •Unstable cardiac disease requiring treatment
- •Congestive heart failure or angina pectoris even if medically controlled
- •Significant arrhythmias
- •History of significant neurologic or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent
- •Active uncontrolled infection
- •Severe hypercalcemia
- •Other serious underlying medical condition that could impair the ability of the patient to participate in the study
- •Neuropathy > grade 1 of any etiology
- •Known DPD deficiency
- •Known severe polyneuropathy
- •Known allergy to Chinese hamster ovary cell proteins, other recombinant human or humanized antibodies, any excipients of bevacizumab formulation, or any other study drugs
- •Chronic inflammatory bowel disease
- •Acute or subacute intestinal occlusion
- •History of previous arterial thromboembolism
- •Uncontrolled hypertension
- •Evidence of bleeding diathesis or coagulopathy
- •Serious nonhealing wound, ulcer, or bone fracture
- •History of tumor other than basocellular carcinoma of the skin
- •Peripheral neuropathy > grade 1 of any origin (e.g., alcohol)
- •Significant traumatic injury within 28 days prior to study treatment
- •PRIOR CONCURRENT THERAPY:
- •Exclusion criteria:
- •No prior chemotherapy for metastatic disease
- •Prior adjuvant chemotherapy permitted if interval since last treatment administration and recurrence is > 6 months
- •Major surgical procedure or open biopsy within 28 days prior to study treatment or anticipation of the need for major surgical procedure during the course of the study
- •Treatment in a clinical trial within 30 days prior to study entry
- •Concurrent treatment with other experimental drugs or other anticancer therapy
- •Current or recent use (within 10 days prior to study treatment) of full-dose oral or parenteral anticoagulants for therapeutic purposes
- •Chronic daily treatment with aspirin (> 325 mg/day)
结局指标
主要结局
Pathological complete response rate of lesions of less than or equal to 30 mm in size assessed by pathologic examination in resected specimens
次要结局
- Response as assessed by NCIC criteria
- Toxicity as assessed by NCIC criteria
研究者
研究点 (8)
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