Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

• Status: Unknown status
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Camptothecin; Capecitabine; Irinotecan

Criteria

Inclusion Criteria:

• Patients with rectal adenocarcinoma

• Clinical staged T3/4 or any node-positive disease

• Age of 18-75 years

• Karnofsky Performance Status > 80

• Adequate bone marrow reserve, renal and hepatic functions

• Without previous antitumoural chemotherapy

• No evidence of metastatic disease

• Written informed consent before randomization

• UGT1A1's genotype of 6/6 or 6/7

Exclusion Criteria:

• Clinical staged I or IV

• Age of <18 or >75 years

• Karnofsky Performance Status < 80

• Previous pelvis radiotherapy

• Previous antitumoural chemotherapy

• Clinically significant internal disease

• Refuse to write informed consent before randomization

• UGT1A1's genotype of 7/7