NCT02226289
Unknown
Phase 2
Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment
Sixth Affiliated Hospital, Sun Yat-sen University1 site in 1 country46 target enrollmentSeptember 2020
Overview
- Phase
- Phase 2
- Intervention
- Bevacizumab
- Conditions
- Neoplasm
- Sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Enrollment
- 46
- Locations
- 1
- Primary Endpoint
- Response rate
- Last Updated
- 5 years ago
Overview
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 for metastatic colorectal cancer. The efficacy of bevacizumab with cytotoxic agents in the third-line treatment of patients with mCRC is still unknown.
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 all available cytotoxic chemotherapy
Investigators
Jian Xiao
Associate Professor
Sixth Affiliated Hospital, Sun Yat-sen University
Eligibility 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
- •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).
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
Arms & Interventions
bevacizumab-containing
bevacizumab with the latest received cytotoxic regimen
Intervention: Bevacizumab
Outcomes
Primary Outcomes
Response rate
Time Frame: Baseline and 6 weeks
Percentage of tumor regression
Secondary Outcomes
- Overall survival(From date of treatment until the date of death of any cause, assessed up to 48 months)
- Progression free survival(From date of treatment until the date of disease progression, assessed up to 48 months)
Study Sites (1)
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