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

NCT01474187 | Unknown Phase 1 DMC

• 1 other identifier: FDRT-003
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Keywords

Neoadjuvant chemotherapy; rectal cancer; phase I study; irinotecan

Outcome Measures

Primary Outcomes (1)

• toxicity

  * Grade 4 hemato-toxicity * Grade 3 nonhemato-toxicity (not include grade 3 anal verge skin toxicity)

  5 weeks

Secondary Outcomes (1)

• pathological complete response (pCR)

  within 14days after surgery

Study Arms (1)

Irinotecan

EXPERIMENTAL

irinotecan dose initial from 50mg/m2/week, increased by 15mg/mg/week

Drug: Irinotecan; Drug: Capecitabine; Radiation: Radiotherapy

Interventions

Irinotecan DRUG

initial from 50mg/m2/week and increased by 15mg/m2/week

Irinotecan

Capecitabine DRUG

625mg/m2,bid,d1-5,qw

Also known as: Xeloda

Irinotecan

Radiotherapy RADIATION

50Gy for whole pelvis

Irinotecan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Irinotecan; Capecitabine; Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Therapeutics

Central Study Contacts

Ji Zhu, MD

CONTACT

leo.zhu@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Radiation Oncology, Cancer Hospital

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 18, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2012
• Last Updated: November 18, 2011

Record last verified: 2011-11

Locations

CN (1)