Time Finding Study of Chronomodulated Irinotecan, 5 Fluorouracil, Leucovorin and Oxaliplatin as First or Second Chemotherapy Line Against Metastatic Colorectal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 40
- 主要终点
- Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs at the time of day that allows for the best drug response may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Randomized phase II trial to determine the best time to give irinotecan combined with fluorouracil, leucovorin, and oxaliplatin in treating patients who have colorectal cancer.
详细描述
OBJECTIVES:
- Determine the role of peak delivery time on the tolerability of irinotecan when administered with chronomodulated fluorouracil, leucovorin calcium, and oxaliplatin as first- or second-line therapy in patients with locoregional or metastatic colorectal cancer.
- Determine the antitumor activity of this regimen.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, WHO performance status (0-1 vs 2), and line of treatment (first vs second). Patients are randomized to receive irinotecan at 1 of 6 different times of the day.
Patients receive irinotecan IV over 6 hours on day 1 and fluorouracil IV and leucovorin calcium IV over 11 hours followed by oxaliplatin IV over 11 hours on days 2-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks until disease progression and then every 8 weeks thereafter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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 cancer
- •Unresectable metastatic or locoregional disease
- •At least 1 measurable lesion outside a previously irradiated area or an area treated with physical devices (e.g., cryotherapy, laser, or thermoablation)
- •No prior enrollment in EORTC-05963
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count greater than 2,000/mm^3
- •Platelet count at least 90,000/mm^3
- •Bilirubin no greater than 2 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •No uncontrolled hypercalcemia
- •Cardiovascular:
- •No overt cardiac disease
- •No severe respiratory illness
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Male patients must use effective barrier contraception during and for up to 6 months after study
- •No baseline diarrhea greater than grade I (must have less than 4 stools per 24 hours)
- •No prior grade III or IV toxicity related to irinotecan
- •No sensory or motor neuropathy with functional impairment
- •No prior hypersensitivity to any study drug
- •No other primary tumor except basal cell skin cancer or carcinoma in situ of the cervix
- •No uncontrolled infectious or chronic disease
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent prophylactic growth factor therapy
- •Chemotherapy:
- •At least 1 month since prior chemotherapy
- •No prior irinotecan, fluorouracil, leucovorin calcium, and oxaliplatin as combination therapy
- •Other prior therapy containing irinotecan and/or oxaliplatin allowed
- •No more than 1 prior chemotherapy regimen for metastatic or locoregional disease
- •Adjuvant chemotherapy considered first-line therapy if tumor relapsed within 6 months of completion of therapy
- •Endocrine therapy:
- •No concurrent corticosteroids except for emergencies
- •Radiotherapy:
- •See Disease Characteristics
- •Palliative radiotherapy for bone lesion allowed except for disease progression
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy
次要结局
- Overall survival
- Peak delivery time for CPT11 tolerability over the first 3 courses of treatment in patients who started therapy, excluding those who stopped prior to course 3 for reasons other than toxicity
- Peak delivery time for CPT11 activity over the first 3 courses
- Peak delivery time for CPT11 tolerability and efficacy over the first 6 courses
- Severe toxic events assessed by CTC v2.0 after each course of chemotherapy
- Progression-free survival