A Study of Avastin (Bevacizumab) in Combination With mFOLFOX6 in Treatment-Naïve Patients With Metastatic Colorectal Cancer With or Without K-RAS Mutations, and Comparison to Cetuximab

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01338558
• Other study ID #: ML25686
• Status: Withdrawn
• Phase: Phase 3
• First received: April 18, 2011
• Last updated: November 1, 2016
• Start date: June 2011
• Est. completion date: May 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: National Spanish Agency for Medicines and Sanitary Products
• Study type: Interventional

Clinical Trial Summary

This randomized, open-label study will evaluate the safety and efficacy of Avastin (Bevacizumab) added to standard mFOLFOX6 chemotherapy in treatment-naïve patients with Stage IV metastatic colorectal cancer. According to K-RAS gene mutation status, patients will be assigned or randomized to receive either Avastin 5 mg/kg intravenously (iv) on Day 1 of each 2-week cycle or cetuximab 400 mg/m2 iv on Day 1 followed by 250 mg/m2 iv every week, in addition to mFOLFOX6 every 2 weeks. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients >/= 18 years of age

• Histologically confirmed adenocarcinoma of the colon or rectum

• Stage IV metastatic disease with at least one measurable metastatic lesion according to RECIST criteria

• Tumour tissue sample available for assessment of K-RAS and BRAF genes

• Prior radiotherapy must have been completed 4 weeks before randomization

• Adequate bone marrow, kidney and liver function

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

• Previous chemotherapy for metastatic disease

• Completion of adjuvant treatment for colorectal cancer (Stage I, II and III) in the 12 months preceding randomization

• Prior treatment with bevacizumab, cetuximab or other EGFR inhibitors

• Clinical or radiographic evidence of brain metastases

• Clinically significant cardiovascular disease or disorder

• History of neoplastic disease other than colorectal cancer in the 3 years prior to start of study treatment, except for successfully treated non-invasive carcinomas such as cervical cancer in situ, basal cell carcinoma of the skin or superficial bladder tumours

• HIV, hepatitis B or C infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent
• cetuximab
400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent
• mFOLFOX6
Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria		up to 4 years	No
Secondary	Overall survival		up to 4 years	No
Secondary	Objective response rate		4 years	No
Secondary	Safety: Incidence of adverse events		4 years	No
Secondary	Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30)		up to 4 years	No
Secondary	Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms		up to 4 years	No