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

Primary Purpose

Colorectal Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Raltitrexed

Irinotecan

5-fluorouracil

Leucovorin

About this trial

This is an interventional treatment trial for Colorectal Carcinoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RALIRI

FOLFIRI

Arm Description

Raltitrexed combined with irinotecan

5-fluorouracil,folinate combined with irinotecan

Outcomes

Primary Outcome Measures

progression free survival

Secondary Outcome Measures

overall survival

overall response rate

disease control rate

Number of Participants with Adverse Events

quality of life questionnaire

Full Information

NCT ID

NCT02376452

First Posted

February 12, 2015

Last Updated

March 2, 2015

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT02376452

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Fudan University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RALIRI

Arm Type

Experimental

Arm Description

Raltitrexed combined with irinotecan

Arm Title

FOLFIRI

Arm Type

Placebo Comparator

Arm Description

5-fluorouracil,folinate combined with irinotecan

Intervention Type

Drug

Intervention Name(s)

Raltitrexed

Intervention Description

2mg/m2 iv gtt, d1

Intervention Type

Drug

Intervention Name(s)

Irinotecan

Intervention Description

180 mg/m2 iv gtt, d1

Intervention Type

Drug

Intervention Name(s)

5-fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

5-FU 400mg/m2 iv, 2400mg/m2 civ 46h

Intervention Type

Drug

Intervention Name(s)

Leucovorin

Other Intervention Name(s)

Intervention Description

400mg/m2 iv gtt,d1

Primary Outcome Measure Information:

Title

progression free survival

Time Frame

2 months

Secondary Outcome Measure Information:

Title

overall survival

Time Frame

6 months

Title

overall response rate

Time Frame

2 months

Title

disease control rate

Time Frame

2 months

Title

Number of Participants with Adverse Events

Time Frame

2 months

Title

quality of life questionnaire

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wen Zhang

Phone

8621-64175590-65242

First Name & Middle Initial & Last Name or Official Title & Degree

Wenhua Li

Phone

8621-64175590-65197

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wen Zhang

Organizational Affiliation

Medical Oncology, Fudan University Shanghai Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fudan University Cancer Hospital

City

ShangHai

State/Province

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jin Li, PhD, M.D

Phone

862164175590

Ext

1108

fudanlijin@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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