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

March 2, 2015 updated by: Jin Li, Fudan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wen Zhang
  • Phone Number: 8621-64175590-65242

Study Contact Backup

  • Name: Wenhua Li
  • Phone Number: 8621-64175590-65197

Study Locations

  • China
    • Shanghai
      • ShangHai, Shanghai, China
        • Recruiting
        • Fudan University Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RALIRI
Raltitrexed combined with irinotecan
Drug: Raltitrexed
2mg/m2 iv gtt, d1
Drug: Irinotecan
180 mg/m2 iv gtt, d1
Placebo Comparator: FOLFIRI
5-fluorouracil,folinate combined with irinotecan
Drug: Irinotecan
180 mg/m2 iv gtt, d1
Drug: 5-fluorouracil
5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
Other Names:
  • 5-FU
Drug: Leucovorin
400mg/m2 iv gtt,d1
Other Names:
  • LV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression free survival
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 6 months
6 months
overall response rate
Time Frame: 2 months
2 months
disease control rate
Time Frame: 2 months
2 months
Number of Participants with Adverse Events
Time Frame: 2 months
2 months
quality of life questionnaire
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Wen Zhang, Medical Oncology, Fudan University Shanghai Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 12, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2015

Last Update Submitted That Met QC Criteria

March 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RALIRI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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