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

Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02226289

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

15.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neoplasm Colorectal Cancer Metastatic Neoplasm	Drug: Bevacizumab	Phase 2

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment

Anticipated Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bevacizumab-containing bevacizumab with the latest received cytotoxic regimen	Drug: Bevacizumab bevacizumab with the latest received cytotoxic regimen Other Names: Avastin

Arm

Intervention/Treatment

Experimental: bevacizumab-containing

bevacizumab with the latest received cytotoxic regimen

Drug: Bevacizumab

bevacizumab with the latest received cytotoxic regimen

Other Names:

Avastin

Outcome Measures

Primary Outcome Measures

Response rate [Baseline and 6 weeks]
Percentage of tumor regression

Secondary Outcome Measures

Overall survival [From date of treatment until the date of death of any cause, assessed up to 48 months]
From date of treatment until the date of death of any cause
Progression free survival [From date of treatment until the date of disease progression, assessed up to 48 months]
From date of treatment until the date of disease progression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.