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

Colorectal Cancer Clinical Trial

— BATTLE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02226289
• Other study ID #: BATTLE
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2020
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: Jian Xiao, Ph D
• Phone: 86-20-38250745
• Email: xiaoj26[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Neoplasm
• Neoplasm
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Bevacizumab
bevacizumab with the latest received cytotoxic regimen

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

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