Clinical trial NCT02226289: Bevacizumab-containing Regimen for Metastatic Colorectal Cancer Failed to Cytotoxic Treatment
Official title: Phase II Study of Bevacizumab-containing Regimen in Patients With Metastatic Colorectal Cancer Who Failed to Cytotoxic Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Neoplasm
Colorectal Cancer
Metastatic Neoplasm
Keywords: bevacizumab
refractory
colorectal cancer
metastatic
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Primary outcomes:
measure: Response rate
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: From date of treatment until the date of death of any cause, assessed up to 48 months
measure: Progression free survival
timeFrame: From date of treatment until the date of disease progression, assessed up to 48 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Sixth Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
name: Ping Lan, Ph D
role: PRINCIPAL_INVESTIGATOR
References: