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

Advanced Colorectal Cancer Clinical Trial

Official title:

A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03126071
• Other study ID #: RBACC
• Status: Recruiting
• Phase: Phase 2
• Start date: February 15, 2017
• Est. completion date: February 15, 2023

Study information

• Verified date: August 2021
• Source: Jiangsu Cancer Institute & Hospital
• Contact: Liangjun Zhu
• Phone: +8613905199123
• Email: zhulj98[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 15, 2023
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Raltitrexed
Raltitrexed:3mg/m2,iv 15min,d1,q3w.
• Irinotecan
Irinotecan:250mg/m2,iv 90min,d1,q3w.
• Oxaliplatin
Oxaliplatin:130mg/m2,iv 120min,d1,q3w.
• Bevacizumab
Bevacizumab:75mg/kg,iv 30min,d1,q3w.

Locations

Country	Name	City	State
China	Jiangsu Cancer Institute & Hospital	Nanjing	Jiangsu
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	Rui Jin Hospital Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression Free Survival	6 months
Secondary	OS	Overall Survival	15 months
Secondary	ORR	Objective Response Rate	36 months
Secondary	DCR	Disease Control Rate	36 months
Secondary	AEs	Percentage of participants experiencing grade 3-5 adverse events	36 months