NCT00101686已完成3 期
A Randomized, Multi-Center Phase III Trial Of Irinotecan In Combination With Three Different Methods Of Administration Of Fluoropyrimidine: Infusional 5-FU (FOLFIRI), Modified-Bolus 5-FU (Day 1 & 8), And Oral Capecitabine (Day 1-14); With Celecoxib Versus Placebo As First-Line Treatment For Patients With Metastatic Colorectal Cancer Study Amended April 23, 2004 To Include Bevacizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 547
- 试验地点
- 1
- 主要终点
- Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
研究概览
简要总结
This study compares in the first study period combination of Irinotecan with three different methods of administration by Fluoropyrimidine. (ie. infusion, bolus and oral). In the second period of study it compares FOLFIRI [a chemotherapy regime that combines bolus irinotecan and leucovorin [LV] with infusional 5-fluorouracil (5-FU)] + bevacizumab and mlFL + bevacizumab. Measures of efficacy and safety will be reported.
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
- •Diagnosis of colorectal cancer (either newly diagnosed or recurrent disease) with evidence of metastatic disease. (Stage IV distant disease)
- •Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
- •An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
- •The primary cancer was a Duke's A or B
- •Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.
排除标准
- •Patients who received any prior systemic anticancer therapy for metastatic colorectal cancer (e.g., chemotherapy, antibody therapy, immunotherapy, gene therapy, vaccine therapy, cytokine therapy, or other experimental agents).
- •Patients cannot have concurrent malignancies at study entry.
- •Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.
研究组 & 干预措施
Modified Bolus 5-FU/LV with Irinotecan
Experimental
干预措施: Modified Bolus 5-FU/LV with Irinotecan (Drug)
FOLFIRI + bevacizumab
Experimental
干预措施: FOLFIRI + bevacizumab (Drug)
miFL + bevacizumab
Experimental
干预措施: miFL + bevacizumab (Drug)
Infusional 5-FU/LV with Irinotecan
Experimental
干预措施: Infusional 5-FU/LV with Irinotecan (Drug)
Oral Capecitabine with Irinotecan
Other
干预措施: Oral Capecitabine with Irinotecan (Drug)
结局指标
主要结局
Time to Progression (TTP) at Primary Completion: FOLFIRI and mIFL
时间窗: every 6 weeks until disease progression
Time to disease progression is defined as the number of months from date of randomization to the date of first documentation of disease progression (PD).
次要结局
- Time to Progression: FOLFIRI, mIFL and CapeIRI(every 6 weeks until disease progression)
- Overall Response: FOLFIRI, mIFL and CapeIRI(every 6 weeks during chemotherapy until disease progression)
- Survival Time: FOLFIRI, mIFL and CapeIRI(assessed at least every week during treatment and at least every 3 months during follow-up)
- 1 Year Survival: FOLFIRI, mIFL and CapeIRI(1 year from date of randomization)
- Time to Progression : Celecoxib and Placebo(every 6 weeks until disease progression)
- Overall Response: Celecoxib and Placebo(every 6 weeks during chemotherapy until disease progression)
- Survival Time: Celecoxib and Placebo(assessed at least every week during treatment and at least every 3 months during follow-up)
- Time to Progression: Bevacizumab With FOLFIRI, mIFL(every 6 weeks until disease progression)
- Overall Response: Bevacizumab With FOLFIRI, mIFL(every 6 weeks during chemotherapy until disease progression)
- 1 Year Survival: Bevacizumab With FOLFIRI, mIFL(1 year from date of randomization)
- Survival Time at Last Follow-Up Visit: Bevacizumab With FOLFIRI, mIFL(Last Follow-Up Visit)
- Dose Reduction Due to Treatment Emergent Adverse Events(Day 1; Day 8; and at end of every 3 treatment cycles for FOLFIRI; end of every 2 cycles for mIRI)
- Overall Relative Dose Intensity of Irinotecan(End of treatment cycle)
研究者
研究点 (1)
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