Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
NCT ID: NCT03126071
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
100 participants
INTERVENTIONAL
2017-02-15
2023-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
Raltitrexed
Raltitrexed:3mg/m2,iv 15min,d1,q3w.
Irinotecan
Irinotecan:250mg/m2,iv 90min,d1,q3w.
Bevacizumab
Bevacizumab:75mg/kg,iv 30min,d1,q3w.
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)
Raltitrexed
Raltitrexed:3mg/m2,iv 15min,d1,q3w.
Oxaliplatin
Oxaliplatin:130mg/m2,iv 120min,d1,q3w.
Bevacizumab
Bevacizumab:75mg/kg,iv 30min,d1,q3w.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Jiangsu Cancer Institute & Hospital
OTHER
Responsible Party
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Liangjun Zhu M.M.
Ward Director of Internal Medicine
Locations
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Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China
Nantong Tumor Hospital
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Jun Zhang, M.D.
Role: primary
References
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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.
Other Identifiers
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RBACC
Identifier Type: -
Identifier Source: org_study_id
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