Colonic Neoplasms Clinical Trial
Official title:
Comparison of Standard and High Dose Irinotecan Based on UGT1A1 Genotype, 5-fluorouracil, and Leucovorin (FOLFIRI) for First-line Treatment of Locally Advanced Colon Cancer: a Prospective Phase II Clinical Study
In the current treatment of colon cancer, the definition of locally advanced colon cancer
(LACC) is controversial, and the clinical trial evidence which support treatment for LACC is
not clear. Irinotecan (CPT-11) combined with fluoropyrimidine (5FU, capecitabine) is main
chemotherapy regimen for patients with advanced colorectal cancer. Whether this regimen also
could be effectively applied for patients with locally advanced colon cancer? It is worthy
of clinicians to conduct research. In recent studies, the literature indicated that the the
uridine diphosphate glucuronide transfer enzyme (UGT1A1) is an important metabolic enzymes
associated with drug metabolism of CPT-11. The gene polymorphism of UGT1A1 is related to
delayed diarrhea and neutropenia caused by irinotecan. Irinotecan dose-exploration study
found that the maximum tolerated dose for irinotecan in patients with UGT1A1*28 homozygous
variant genotypes was significantly lower compared with the wild genotype. The studies based
on Asian patients suggested that the gene variant of UGT1A1*6 also have similar impacts. At
present, the studies of irinotecan dose adjustment based on the UGT1A1 gene polymorphisms
has not yet come to the consistency of conclusions. The frequency of UGT1A1 gene
polymorphisms between different races is significant different, irinotecan dose exploratory
study based on Chinese patients has not been carried out.
This study focus on prospectively adverse reactions, optimal efficacy and R0 resection rate
of the patients with LACC who treated by dose-adjusted irinotecan based on the genotypes of
UGT1A1.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 to 70 years old, male or female; 2. ECOG performance status of 0-1; 3. Confirm the diagnosis pathologically locally advanced colon adenocarcinoma; 4. TNM stage is T4NxM0; 5. According to RECIST 1.1 version of the standard, at least measurable lesions without local treatment; spiral CT or magnetic resonance imaging (MRI), thickness = 5 mm lesion diameter = 10mm, such as lymph short diameter required = 15mm; 6. Each organ function was normal (in the case of no ongoing support therapy, enrolled within one week of the laboratory examination results); 1)absolute neutrophil count (ANC) = 1.5x109 / L, platelet count = 80x109 / L, hemoglobin 9g/dL; 2)serum total bilirubin = 1.5 times the upper limit of normal; 3)ALT and AST = 2.5 times the upper limit of normal without liver metastases, liver metastases = upper limit of normal in ALT and AST 5 times; 4)= upper limit of normal, serum creatinine or creatinine clearance = 50ml/min. 7. This study has been fully understood and voluntarily signed the informed consent form; 8. Expected to survive for more than three months. Exclusion Criteria: 1. Pregnancy or lactating women or fertility patients are reluctant to take contraceptive measures; 2. who are allergic to irinotecan, fluorouracil; 3. can not be controlled in the central nervous system (CNS) metastasis; 4. Suffering from any other malignancy (fully cured carcinoma in situ of the cervix or basal cell or squamous cell skin cancer excluded) within five years. 5.Clinical uncontrolled active infection such as acute pneumonia, with active hepatitis B; 6.with severe systemic disease, including, but not limited to, cerebrovascular disease, uncontrolled diabetes, uncontrolled hypertension, acute myocardial infarction, unstable angina, congestive heart failure, severe arrhythmia, thrombosis occurred within 6 months or embolic events (including transient ischemic attack); 7.Acute or subacute intestinal obstruction; 8.Symptoms of ascites, pleural effusion, and pericardial effusion, can not draining or symptomatic treatment control; 9.according to the NCI CTC AE 3.0 standard 2 or more than 2 toxicity or researchers believe that patients with any clinical or laboratory abnormalities are unfit to participate in the clinical research; 10.Also accept other systemic anti-cancer therapy (local radiotherapy of bone metastases from this restriction) to accept other trial medication in the 4 weeks before the start of the study; 11.History of serious psychological or psychiatric disorders, drug addiction or alcohol dependent persons; 12.estimated that the lack of compliance of patients enrolled in the clinical study. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences | Harbin | Heilongjiang |
Lead Sponsor | Collaborator |
---|---|
Colorectal Cancer Institute of the Heilongjiang Academy of Medical Sciences |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | adverse reactions | one year | Yes | |
Primary | R0 resection rate | one year | No | |
Secondary | disease free survival | one year | No |
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