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

This study is currently recruiting participants.
Verified November 2011 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Zhu Ji, Fudan University
ClinicalTrials.gov Identifier:
NCT01474187
First received: November 11, 2011
Last updated: November 15, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
 Drug: Irinotecan
Drug: Capecitabine
Radiation: Radiotherapy
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • toxicity [ Time Frame: 5 weeks ] [ Designated as safety issue: Yes ]
    • Grade 4 hemato-toxicity
    • Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)


Secondary Outcome Measures:
  • pathological complete response (pCR) [ Time Frame: within 14days after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Irinotecan
irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week
 Drug: Irinotecan
initial from 50mg/m2/week and increased by 15mg/m2/week
Drug: Capecitabine
625mg/m2,bid,d1-5,qw
Other Name: Xeloda
Radiation: Radiotherapy
50Gy for whole pelvis

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474187

Contacts
Contact: Ji Zhu, MD leo.zhu@126.com

Locations
China, Shanghai
Cancer Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Ji Zhu, MD         leo.zhu@126.com    
Principal Investigator: Zhen Zhang, MD            
Sub-Investigator: Ji Zhu, MD            
Sponsors and Collaborators
Fudan University
  More Information

No publications provided

Responsible Party: Zhu Ji, Chief of Department of Radiation Oncology, Cancer Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT01474187     History of Changes
Other Study ID Numbers: FDRT-003
Study First Received: November 11, 2011
Last Updated: November 15, 2011
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
Neoadjuvant chemotherapy
rectal cancer
phase I study
irinotecan

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Capecitabine
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on June 18, 2013