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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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01338558
First received: April 18, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
 Drug: bevacizumab [Avastin]
Drug: cetuximab
Drug: mFOLFOX6
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival: native versus mutated K-RAS; tumour assessments according to RECIST criteria [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Objective response rate [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Quality of Life: European Organisation for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30) [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • Progression-free survival: comparison of the two treatment regimens in the native K-RAS arms [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: June 2011
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: K-RAS mutated Drug: bevacizumab [Avastin]
5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent
Drug: mFOLFOX6
Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
Experimental: K-RAS native A Drug: bevacizumab [Avastin]
5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent
Drug: mFOLFOX6
Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
Active Comparator: K-RAS native B 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
Drug: mFOLFOX6
Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338558

Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01338558     History of Changes
Other Study ID Numbers: ML25686
Study First Received: April 18, 2011
Last Updated: June 3, 2013
Health Authority: Spain: National Spanish Agency for Medicines and Sanitary Products

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Bevacizumab
Cetuximab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013