Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment

• Status: Not yet recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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 for metastatic colorectal cancer. The efficacy of bevacizumab with cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.