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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01736904
• Other study ID #: wXELIRI vs FOLFIRI in CRC
• Status: Recruiting
• Phase: Phase 2
• First received: November 21, 2012
• Last updated: November 26, 2012
• Start date: May 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2012
• Source: Fudan University
• Contact: Jin Li, PhD,MD
• Phone: 64175590-5109
• Email: fudanlijin[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• wXELIRI regimen
irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
• FOLFIRI regimen
irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall survival which is calculated from the start to treatment to the death		eight months	Yes
Primary	Progression free survival which is calculated from the start of treatment to disease progression or death		eight weeks	Yes
Secondary	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	Yes