Status:
UNKNOWN
Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Neoplasm
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Bevacizumab, a humanized monoclonal antibody against vascular endothelial growth factor (VEGF), combined with fluoropyrimidine-based chemotherapy is now the standard first and second-line treatment fo...
Detailed Description
This is a single arm, phase II, open-labelled clinical trial to evaluate the safety and efficacy of bevacizumab combined with cytotoxic agents in the treatment of patients with mCRC progressing under ...
Eligibility Criteria
Inclusion
- Signed informed consent obtained.
- Subjects must be able to understand and willing to sign a written informed consent.
- Subjects \> 18 years of age
- Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2.
- Histological or cytological diagnosis of adenocarcinoma of the colon or rectum.
- Subjects have unresectable metastatic lesions.
- Subjects failed to respond to oxaliplatin, irinotecan and fluorouracil.
- Subjects have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria measured within 4 weeks prior to registration.
- Leukocytes ≥ 3.0 x109/ L, absolute neutrophil count (ANC) ≥ 1.5 x109/ L, platelet count ≥ 100 x109/ L, hemoglobin (Hb) ≥ 9g/ dL.
- Total bilirubin ≤1.5 x the upper limit of normal (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 x ULN.
- Amylase and lipase ≤ 1.5 x the ULN.
- Serum creatinine ≤ 1.5 x the ULN.
- Calculated creatinine clearance or 24 hour creatinine clearance ≥ 50 mL/ min.
Exclusion
- Any previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer within 5 years prior to this study.
- Extended field radiotherapy within 4 weeks or limited field radiotherapy within 2 weeks prior to randomization.
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks before start of study medication.
- Uncontrolled hypertension. (systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg despite optimal medical management).
- Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment or a history of ventricular arrhythmia
- Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months before start of study medication.
- Any evidence of active infection.
- Known history of human immunodeficiency virus (HIV) infection.
- History of bleeding diathesis or coagulopathy.
- History of interstitial pneumonitis or pulmonary fibrosis
- Pregnancy or lactation at the time of study entry.
- Any history of or currently known brain metastases.
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Any illness or medical conditions that are unstable or could jeopardize the safety of the subjects and his/her compliance in the study.
- Subjects with known allergy to the study drugs or to any of its excipients.
- Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT02226289
Start Date
September 1 2020
End Date
December 1 2020
Last Update
September 2 2020
Active Locations (1)
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1
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655