NCT00975897已完成2 期
FOCUS 3 - A Study to Determine the Feasibility of Molecular Selection of Therapy Using KRAS, BRAF and Topo-1 in Patients With Metastatic or Locally Advanced Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3,240
- 试验地点
- 3
- 主要终点
- Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration
研究概览
简要总结
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors select the best treatment for patients and predict their response to treatment.
PURPOSE: This randomized phase II/III trial is studying how well tumor tissue testing works in selecting treatment for patients with metastatic or locally advanced colorectal cancer.
详细描述
OBJECTIVES:
Primary - Feasibility Study
- To determine the proportion of consenting patients that can provide a formalin-fixed paraffin-embedded block containing tumor.
- To determine the feasibility of topoisomerase-1 (topo-1) IHC and K-ras, BRAF mutational status determination being completed with 10 working days of initial consent.
- To determine reproducibility of results between reference laboratories.
- To determine the real costs of molecular testing.
- To determine the patients' ability to comprehend the study and their attitude during the waiting period for testing.
- To assess patients' ability to fully comprehend the trial as explained to them.
Secondary - Feasibility Study
- To further identify the EGFR-responsive subset within the K-ras wildtype population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal adenocarcinoma meeting 1 of the following criteria:
- •Prior or recurrent primary adenocarcinoma of the colon or rectum with clinical or radiological evidence of locally advanced or metastatic disease
- •Metastatic adenocarcinoma with clinical and/or radiological evidence of colorectal primary tumor
- •Inoperable metastatic or locoregional disease
- •Patients suitable for surgical resection of metastatic disease after response to first-line or adjuvant chemotherapy not allowed and should be considered for the New-EPOC trial study
- •Unidimensionally measurable disease (according to RECIST criteria)
- •Must have completed adjuvant chemotherapy with fluorouracil +/- leucovorin calcium (FU +/- LC), capecitabine, or oxaliplatin combinations in the past 6 months
- •QUASAR 2 patients who have continued bevacizumab for 6 months following completion of chemotherapy are allowed immediately after completion of bevacizumab
- •Rectal chemotherapy with FU +/- LC or capecitabine for allowed if completed ≥ 1 month ago
- •Single tumor block available
- •No brain metastasis
- •PATIENT CHARACTERISTICS:
- •WHO performance status 0-2
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
- •Serum bilirubin ≤ 1.25 times ULN
- •AST or ALT ≤ 2.5 times ULN
- •Creatinine clearance ≥ 30 mL/min OR GFR ≥ 30 mL/min
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Considered fit to undergo combination chemotherapy, with none of the following conditions:
- •Severe uncontrolled concurrent medical illness likely to interfere with protocol treatments, including any of the following:
- •Poorly controlled angina
- •Uncontrolled hypertension
- •Myocardial infarction within the past 3 months
- •History of severe peptic ulcer disease
- •Any psychiatric or neurological condition that is likely to compromise the patient's ability to give informed consent or to comply with oral medication
- •Nephrotic syndrome
- •Known coagulopathy
- •No prior or current malignant disease that, in the judgement of the treating investigator, is likely to interfere with FOCUS 3 treatment or assessment of response
- •No known hypersensitivity reactions to any of the components of the study treatments
- •No personal or family history suggestive of dihydropyrimidine dehydrogenase (DPD) deficiency or with known DPD deficiency
- •No history of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant precluding informed consent
- •Not able to attend or comply with treatment or follow-up scheduling
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 4 weeks since prior surgery
- •No prior systemic chemotherapy for metastatic disease
- •No ongoing therapy with cyclosporin-A
- •No ongoing treatment with a contraindicated concomitant medication
排除标准
- 未提供
结局指标
主要结局
Topoisomerase-1 (topo-1) and K-ras, BRAF results obtained within 10 working days after registration
Number of patients in which the interval between registration and randomization (RZ) is ≤ 10 days
Efficacy of fluorouracil with vs without irinotecan hydrochloride, fluorouracil, and leucovorin calcium (IrMdG) in low topo-1 tumors
Progression-free survival of patients with high topo-1 tumors treated with IrMdG with or without oxaliplatin
Efficacy of IrMdG with vs without cetuximab in K-ras wildtype tumors
Efficacy of IrMdG with vs without bevacizumab in K-ras mutant tumors
次要结局
- Time from release of tumor block to receipt by pathology lab
- If applicable, reason that RZ did not occur
- Time from registration to treatment start
- Time from data presentation to investigator to date of RZ
- Reproducibility of K-ras, BRAF, and topo-1 results
- Distribution frequencies
- Costs of molecular testing
- Toxicity according to NCI CTCAE v.3
- Response rates
- Progression-free survival
- Attitudes of patients about tests and treatment
研究者
研究点 (3)
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