Back to resultsRaltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
Primary Purpose
Advanced Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Raltitrexed
Irinotecan
Oxaliplatin
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Colorectal Cancer
Eligibility Criteria
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.
Sites / Locations
- Jiangsu Cancer Institute & HospitalRecruiting
- Nantong Tumor Hospital
- The First Affiliated Hospital of Soochow UniversityRecruiting
- Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)
Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)
Arm Description
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)
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)
Outcomes
Primary Outcome Measures
PFS
Progression Free Survival
Secondary Outcome Measures
OS
Overall Survival
ORR
Objective Response Rate
DCR
Disease Control Rate
AEs
Percentage of participants experiencing grade 3-5 adverse events
Full Information
NCT ID
NCT03126071
First Posted
April 20, 2017
Last Updated
August 27, 2021
Sponsor
Jiangsu Cancer Institute & Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03126071
Brief Title
Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
Official Title
A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
August 15, 2022 (Anticipated)
Study Completion Date
February 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangsu Cancer Institute & Hospital
4. Oversight
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
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Colorectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)
Arm Type
Experimental
Arm Description
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)
Arm Title
Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Raltitrexed
Intervention Description
Raltitrexed:3mg/m2,iv 15min,d1,q3w.
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
Irinotecan:250mg/m2,iv 90min,d1,q3w.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin:130mg/m2,iv 120min,d1,q3w.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Intervention Description
Bevacizumab:75mg/kg,iv 30min,d1,q3w.
Primary Outcome Measure Information:
Title
PFS
Description
Progression Free Survival
Time Frame
6 months
Secondary Outcome Measure Information:
Title
OS
Description
Overall Survival
Time Frame
15 months
Title
ORR
Description
Objective Response Rate
Time Frame
36 months
Title
DCR
Description
Disease Control Rate
Time Frame
36 months
Title
AEs
Description
Percentage of participants experiencing grade 3-5 adverse events
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liangjun Zhu
Phone
+8613905199123
Email
zhulj98@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuejiao Zhong, M.D.
Phone
+8613770575447
Email
zhongyuejiao@163.com
Facility Information:
Facility Name
Jiangsu Cancer Institute & Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liangjun Zhu
Phone
+8613905199123
Email
zhulj98@foxmail.com
First Name & Middle Initial & Last Name & Degree
Yuejiao Zhong
Phone
+861370575447
Email
zhongyuejiao@163.com
Facility Name
Nantong Tumor Hospital
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226000
Country
China
Individual Site Status
Active, not recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunrong Zhu, M.D.
Phone
+8613063870566
Email
zcr050311@163.com
First Name & Middle Initial & Last Name & Degree
Feng Xiong
Phone
+8613270971002
Email
greenlemontea@126.com
Facility Name
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, M.D.
12. IPD Sharing Statement
Learn more about this trial
Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
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