Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
1 other identifier
interventional
100
1 country
4
Brief Summary
The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2017
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2017
CompletedFirst Submitted
Initial submission to the registry
April 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedAugust 30, 2021
August 1, 2021
5.5 years
April 20, 2017
August 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
PFS
Progression Free Survival
6 months
Secondary Outcomes (4)
OS
15 months
ORR
36 months
DCR
36 months
AEs
36 months
Study Arms (2)
Raltitrexed and Irinotecan（RALIRI） plus Bevacizumab(AVASTIN)
EXPERIMENTALIrinotecan: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)
Raltitrexed and Oxaliplatin（RALOX） plus Bevacizumab(AVASTIN)
EXPERIMENTALOxaliplatin: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)
Interventions
Raltitrexed:3mg/m2,iv 15min,d1,q3w.
Irinotecan:250mg/m2,iv 90min,d1,q3w.
Oxaliplatin:130mg/m2,iv 120min,d1,q3w.
Bevacizumab:75mg/kg,iv 30min,d1,q3w.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226000, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Related Publications (1)
Li S, Li X, Zhu Q, Gao J, Zhu C, Zhu L. Raltitrexed Chemotherapy Regimen Plus Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer: A Prospective Multicenter Phase II Trial. Cancer Control. 2024 Jan-Dec;31:10732748241275012. doi: 10.1177/10732748241275012.
PMID: 39286935DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ward Director of Internal Medicine
Study Record Dates
First Submitted
April 20, 2017
First Posted
April 24, 2017
Study Start
February 15, 2017
Primary Completion
August 15, 2022
Study Completion
February 15, 2023
Last Updated
August 30, 2021
Record last verified: 2021-08