wXELIRI Versus FOLFIRI Regimen in the Treatment of Advanced Colorectal Cancer Patients

A Multicenter, Randomized Phase II Study of Weekly XELIRI Regimen Versus FOLFIRI in the Treatment of Advanced Colorectal Cancer Patients

The aim of this study is to compare weekly-XELIRI(wXELIRI) regimen versus FOLFIRI regimen in the treatment of advanced colorectal cancer patients. The hypothesis is the efficacy of wXELIRI is not less than FOLFIRI with tolerable toxicity.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: FOLFIRI regimen; Drug: wXELIRI regimen

Detailed Description

The combination of irinotecan and fluorouracil drugs regimen is frequently used in patients with advanced colorectal cancer. According to the previous data, higher rate of diarrhea was observed in the combination of irinotecan and capecitabine (XELIRI) regimen, compared to the combination of irinotecan and 5-fluorouracil (FOLFIRI) regimen. However, the modified weekly XELIRI regimen, which was investigated in our previous single armed study, show tolerate toxicities compared with FOLFIRI, without compromising efficacy. It is supposed that wXELIRI regimen is no less less than FOLFIRI regimen in efficacy.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jin Li, PhD,MD; Phone Number: 64175590-5109; Email: fudanlijin@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Cancer Hospital
      • Principal Investigator: Jin Li, PhD,MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Second-line treatment for advanced colorectal cancer,irinotecan was not previously used.
• Age range 18-70 years old
• ECOG performance status 0-1
• Life expectancy of more than 3 months
• Adequate organ function

Exclusion Criteria:

• Previous serious cardiac disease
• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• chronic inflammatory bowel disease or intestinal obstruction
• Serious uncontrolled diseases and intercurrent infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: FOLFIRI; FOLFIRI regimen	Drug: FOLFIRI regimen; irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks; Other Names: FOLFIRI
Experimental: wXELIRI regimen; wXELIRI	Drug: wXELIRI regimen; irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days; Other Names: wXELIRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival which is calculated from the start of treatment to disease progression or death	eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate which includes complete response(CR) and partial response(PR) participants	Objective response rate (ORR)= CR(complete response)+PR(partial response)	eight weeks

Other Outcome Measures

Outcome Measure	Time Frame
Overall survival which is calculated from the start to treatment to the death	eight months

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Jin Lin, PhD, MD, Fudan University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: November 21, 2012
• First Submitted That Met QC Criteria: November 26, 2012
• First Posted (Estimate): November 29, 2012

Study Record Updates

• Last Update Posted (Estimate): November 29, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: advanced colorectal cancer; FOLFIRI; XELIRI
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: wXELIRI vs FOLFIRI in CRC