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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

NCT ID: NCT01338558

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2015-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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K-RAS mutated

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent

mFOLFOX6

Intervention Type DRUG

Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent

K-RAS native A

Group Type EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type DRUG

5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent

mFOLFOX6

Intervention Type DRUG

Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent

K-RAS native B

Group Type ACTIVE_COMPARATOR

cetuximab

Intervention Type DRUG

400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent

mFOLFOX6

Intervention Type DRUG

Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent

Interventions

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bevacizumab [Avastin]

5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent

Intervention Type DRUG

cetuximab

400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent

Intervention Type DRUG

mFOLFOX6

Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Other Identifiers

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ML25686

Identifier Type: -

Identifier Source: org_study_id