Colorectal Cancer Clinical Trial
— BATTLEOfficial title:
Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment
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.
Status | Not yet recruiting |
Enrollment | 46 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sixth Affiliated Hospital, Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response rate | Percentage of tumor regression | Baseline and 6 weeks | |
Secondary | Overall survival | From date of treatment until the date of death of any cause | From date of treatment until the date of death of any cause, assessed up to 48 months | |
Secondary | Progression free survival | From date of treatment until the date of disease progression | From date of treatment until the date of disease progression, assessed up to 48 months |
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