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

NCT02226289 | Unknown Phase 2 DMC

• 1 other identifier: BATTLE
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasm; Colorectal Cancer; Metastatic Neoplasm

Keywords

bevacizumab; refractory; colorectal cancer; metastatic

Outcome Measures

Primary Outcomes (1)

• Response rate

  Percentage of tumor regression

  Baseline and 6 weeks

Secondary Outcomes (2)

• 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 Arms (1)

bevacizumab-containing

EXPERIMENTAL

bevacizumab with the latest received cytotoxic regimen

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

bevacizumab with the latest received cytotoxic regimen

Also known as: Avastin

bevacizumab-containing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

Location

MeSH Terms

Conditions

Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ping Lan, Ph D

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Xiao, Ph D

CONTACT

86-20-38250745; xiaoj26@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 25, 2014
• First Posted: August 27, 2014
• Study Start: September 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)