Individual Dosage Selection of Irinotecan (CPT-11) Based on UGT1A1 Genotype in Metastatic Colorectal Cancer Patients
Metastatic Colorectal Cancer
About this trial
This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring Colorectal cancer, Irinotecan, UGT1A1 genotype, Neutropenia, diarrhea, response, pharmacokinetic
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed colorectal cancer patients who received no prior chemotherapy or failed to 1st line treatments
- At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- Aged 18 years or older
- ECOG performance status of ≤ 2.
- Anticipated life expectancy of ≥ 3 months.
- UGT1A1 genotype tested. Categorized into Wild (UGT1A1*1/*1), Hetero (UGT1A1*1/ *28, UGT1A1*1/ *6), and Homo (UGT1A1*28/*28, UGT1A1*6/*6, UGT1A1*28/*6).
Adequate organ function, including bone marrow, kidney and liver.
- ANC ≥ 1.5×109/L and hemoglobin ≥ 9g/dL and platelet count ≥ 100×109/L
- Serum total bilirubin ≤ 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Serum ALT and AST ≤ 2.5 x ULN (Serum ALT and AST ≤ 5 x ULN, if liver metastases are present)
- Serum creatinine ≤ 1.5 x ULN or CLcr > 60 ml/min
- Written informed consent can be obtained prior to their participation in the trial.
Exclusion Criteria:
- Pregnant or breast feeding women.
- Subjects who have previously received CPT-11 treatment.
- Serious concurrent complication, severe active infection.
- Subjects with chronic diarrhea, acute or sub acute Intestinal obstruction.
- Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
- Subjects who are regarded to be unsuitable for this trial by the investigator.
- Subjects who are participating in other clinical trials.
Sites / Locations
- Affiliated Hospital Cancer Center, Academy of Military Medical Sciences (307 Hospital of PLA)
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Active Comparator
Standard FOLFIRI for wild/hetero UGT1A1
Reduced Dose of CPT-11 for homo UGT1A1
Standard FOLFIRI for homo UGT1A1
Irinotecan Injection [Camptosar] (CPT-11) 180 mg/m2, day 1; Leucovorin (LV) 400mg/m2, day 1; 5-fluorouracil (5-FU) 400mg/m2, day 1, 5-fluorouracil (5-FU) 2400mg/m2, day 1; Repeat every two weeks.
Irinotecan Injection [Camptosar] (CPT-11) 90 mg/m2, day 1; Leucovorin (LV) 400mg/m2, day 1; 5-fluorouracil (5-FU) 400mg/m2, day 1, 5-fluorouracil (5-FU) 2400mg/m2, day 1; Repeat every two weeks.
Irinotecan Injection [Camptosar] (CPT-11) 180 mg/m2, day 1; Leucovorin (LV) 400mg/m2, day 1; 5-fluorouracil (5-FU) 400mg/m2, day 1, 5-fluorouracil (5-FU) 2400mg/m2, day 1; Repeat every two weeks.