Phase II Study of 2-weekly RAILIRI Versus FOLFIRI as Second-line Treatment in Advanced Colorectal Cancer Patients

Colorectal Carcinoma Clinical Trial

Official title:

Phase II Study of 2-weekly Raltitrexed Plus Irinotecan Regimen (RAILIRI) Versus Fluorouracil, Leucovorin, and Irinotecan Regimen (FOLFIRI) as Second-line Treatment in Advanced Colorectal Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02376452
• Other study ID #: RALIRI
• Status: Recruiting
• Phase: Phase 2
• First received: February 12, 2015
• Last updated: March 2, 2015
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: February 2015
• Source: Fudan University
• Contact: Wen Zhang
• Phone: 8621-64175590-65242
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the efficacy and safety of two-weekly RAILIRI regimen with FOLFIRI regimen in the treatment of advanced colorectal cancer patients in the second-line setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• aged 18-70 years with histologically or cytologically confirmed advanced colorectal adenocarcinoma

• Eastern Cooperative Oncology Group performance status of 0 to 1

• life expectancy of = 3 months

• patients who had failed first-line treatment with either XELOX (capecitabine combined with oxaliplatin) or FOLFOX (5-fluorouracil/leucovorin with oxaliplatin)

• at least one measurable disease lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria

• have adequate bone marrow, hepatic, and renal function

Exclusion Criteria:

• patients with previous chronic inflammatory bowel disease, chronic diarrhea or recurrent bowel obstruction

• patients with symptomatic brain metastases

• active clinical severe infection

• previously received irinotecan or raltitrexed

• dihydropyrimidine dehydrogenase (DPD) enzyme adequate

Study Design

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Drug:
• Raltitrexed
2mg/m2 iv gtt, d1
• Irinotecan
180 mg/m2 iv gtt, d1
• 5-fluorouracil
5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
• Leucovorin
400mg/m2 iv gtt,d1

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
Primary	progression free survival		2 months	No
Secondary	overall survival		6 months	No
Secondary	overall response rate		2 months	No
Secondary	disease control rate		2 months	No
Secondary	Number of Participants with Adverse Events		2 months	Yes
Secondary	quality of life questionnaire		2 months	No