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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Colorectal Cancer
• Intervention / Treatment: Drug: Raltitrexed; Drug: Irinotecan; Drug: Bevacizumab; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yuejiao Zhong, M.D.; Phone Number: +8613770575447; Email: zhongyuejiao@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Recruiting
      • Jiangsu Cancer Institute & Hospital
      • Contact: Yuejiao Zhong; Phone Number: +861370575447; Email: zhongyuejiao@163.com
    • Nantong, Jiangsu, China, 226000
      • Active, not recruiting
      • Nantong tumor hospital
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Chunrong Zhu, M.D.; Phone Number: +8613063870566; Email: zcr050311@163.com
      • Contact: Feng Xiong; Phone Number: +8613270971002; Email: greenlemontea@126.com
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Not yet recruiting
      • Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
      • Contact: Jun Zhang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Bevacizumab; Bevacizumab:75mg/kg,iv 30min,d1,q3w.; Other Names: Avastin; Drug: Oxaliplatin; Oxaliplatin:130mg/m2,iv 120min,d1,q3w.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression Free Survival	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	Overall Survival	15 months
ORR	Objective Response Rate	36 months
DCR	Disease Control Rate	36 months
AEs	Percentage of participants experiencing grade 3-5 adverse events	36 months

Collaborators and Investigators

• Sponsor: Jiangsu Cancer Institute & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2017
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): February 15, 2023

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Topoisomerase Inhibitors; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Topoisomerase I Inhibitors; Folic Acid Antagonists; Oxaliplatin; Bevacizumab; Irinotecan; Raltitrexed
• Other Study ID Numbers: RBACC

Drug and device information, study documents

• 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