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Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer

Sponsor
Jiangsu Cancer Institute & Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03126071
Collaborator
(none)
100
Enrollment
4
Locations
2
Arms
72
Anticipated Duration (Months)
25
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
Actual Study Start Date :
Feb 15, 2017
Anticipated Primary Completion Date :
Aug 15, 2022
Anticipated Study Completion Date :
Feb 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)

Irinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)

Drug: Raltitrexed
Raltitrexed:3mg/m2,iv 15min,d1,q3w.

Drug: Irinotecan
Irinotecan:250mg/m2,iv 90min,d1,q3w.

Drug: Bevacizumab
Bevacizumab:75mg/kg,iv 30min,d1,q3w.
Other Names:
  • Avastin

    		•
    Experimental: Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)

    Oxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)

    Drug: Raltitrexed
    Raltitrexed:3mg/m2,iv 15min,d1,q3w.

    Drug: Oxaliplatin
    Oxaliplatin:130mg/m2,iv 120min,d1,q3w.

    Drug: Bevacizumab
    Bevacizumab:75mg/kg,iv 30min,d1,q3w.
    Other Names:
  • Avastin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PFS [6 months]

      Progression Free Survival

    Secondary Outcome Measures

    1. OS [15 months]

      Overall Survival

    2. ORR [36 months]

      Objective Response Rate

    3. DCR [36 months]

      Disease Control Rate

    4. AEs [36 months]

      Percentage of participants experiencing grade 3-5 adverse events

    Eligibility Criteria

    Criteria

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

    • 18-70 years;

    • histological and/or cytological confirmation of ACC;

    • disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy;

    • at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm（according to RECIST 1.1）

    • ECOG performance status 0-1

    • life expectancy of at least 3 months

    • satisfactory main organ function，laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count（ANC） ≥1.5×109/L, platelet count（PLT） ≥80×109/L, Serum creatinine（CR）≤1.5 upper normal limitation (UNL)，total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Alkaline phosphatase（ALP）≤3 UNL(For patients with liver metastasis, the ALP must be ≤5.0 UNL);

    • written informed consent

    Exclusion Criteria:

    • prior exposure to raltitrexed;

    • Clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (<=6 months before treatment start),congestive heart failure （New York Heart Association ，NYHA>= grade 3）,stroke or transient ischemic attack

    • Accept kidney dialysis treatment now

    • chronic enteropathy on unresolved bowel obstruction;

    • previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin;

    • the UGT1A1 *28（7/7）*6（A/A） gene type;

    • pregnant or lactated women;

    • Unsuitable for the study or other chemotherapy determined by investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jiangsu Cancer Institute & Hospital Nanjing Jiangsu China 210009
    2 Nantong Tumor Hospital Nantong Jiangsu China 226000
    3 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215000
    4 Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Jiangsu Cancer Institute & Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liangjun Zhu M.M., Ward Director of Internal Medicine, Jiangsu Cancer Institute & Hospital
    ClinicalTrials.gov Identifier:
    NCT03126071
    Other Study ID Numbers:
    • RBACC
    First Posted:
    Apr 24, 2017
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Bevacizumab
    Oxaliplatin
    Irinotecan
    Raltitrexed

    Study Results

    No Results Posted as of Aug 30, 2021