Individual Dosage Selection of Irinotecan (CPT-11) Based on UGT1A1 Genotype in Metastatic Colorectal Cancer Patients
NCT ID: NCT01523431
Last Updated: 2017-03-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
583 participants
INTERVENTIONAL
2012-03-08
2016-04-27
Brief Summary
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Detailed Description
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The study is designed to investigate the role of prospectively dose reduction of CPT-11 in toxicity, tumor response and pharmacokinetics for homozygous UGT1A1 patients, and compare these parameters to standard dose of CPT-11 for wild-type, heterozygous or homozygous UGT1A1 patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard FOLFIRI for wild/hetero 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 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 \*1/\*1 or heterozygous UGT1A1\*1/\*28 or \*1/\*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
5-fluorouracil
The 5-FU dosage will remain the standard.
Leucovorin
The LV dosage will remain the standard.
Reduced Dose of CPT-11 for homo UGT1A1
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 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 \*1/\*1 or heterozygous UGT1A1\*1/\*28 or \*1/\*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
5-fluorouracil
The 5-FU dosage will remain the standard.
Leucovorin
The LV dosage will remain the standard.
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 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 \*1/\*1 or heterozygous UGT1A1\*1/\*28 or \*1/\*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
5-fluorouracil
The 5-FU dosage will remain the standard.
Leucovorin
The LV dosage will remain the standard.
Interventions
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Irinotecan Injection [Camptosar]
CPT-11 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 \*1/\*1 or heterozygous UGT1A1\*1/\*28 or \*1/\*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1\*28/\*28, \*6/\*6 or \*28/\*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
5-fluorouracil
The 5-FU dosage will remain the standard.
Leucovorin
The LV dosage will remain the standard.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
3. Aged 18 years or older
4. ECOG performance status of ≤ 2.
5. Anticipated life expectancy of ≥ 3 months.
6. 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).
7. 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
8. Written informed consent can be obtained prior to their participation in the trial.
Exclusion Criteria
2. Subjects who have previously received CPT-11 treatment.
3. Serious concurrent complication, severe active infection.
4. Subjects with chronic diarrhea, acute or sub acute Intestinal obstruction.
5. Subjects with uncontrolled CNS metastasis or epilepsia or severe psychiatric disorders.
6. Subjects who are regarded to be unsuitable for this trial by the investigator.
7. Subjects who are participating in other clinical trials.
18 Years
ALL
No
Sponsors
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The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
OTHER
Responsible Party
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Xu jianming
Director of Department of GI Cancer
Principal Investigators
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Jian-Ming Xu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital, Academy of Military Medical Sciences
Locations
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Affiliated Hospital Cancer Center, Academy of Military Medical Sciences (307 Hospital of PLA)
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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MCRC-307PLAH-XJM
Identifier Type: -
Identifier Source: org_study_id
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