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

Sponsor
Fudan University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02376452
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
27
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Sep 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. progression free survival [2 months]

    Secondary Outcome Measures

    1. overall survival [6 months]

    2. overall response rate [2 months]

    3. disease control rate [2 months]

    4. Number of Participants with Adverse Events [2 months]

    5. quality of life questionnaire [2 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fudan University Cancer Hospital ShangHai Shanghai China

    Sponsors and Collaborators

    • Fudan University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jin Li, Fudan University Shanghai Cancer Center, Fudan University
    ClinicalTrials.gov Identifier:
    NCT02376452
    Other Study ID Numbers:
    • RALIRI
    First Posted:
    Mar 3, 2015
    Last Update Posted:
    Mar 3, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Leucovorin
    Fluorouracil
    Raltitrexed
    Irinotecan

    Study Results

    No Results Posted as of Mar 3, 2015