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A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01159171
First received: July 7, 2010
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.


Condition Intervention Phase
Colorectal Cancer
 Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Drug: oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of the Combination of Bevacizumab (rhuMab VEGF) and Oxaliplatin Plus Capecitabine (XELOX) in Patients With Advanced Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall response rate (ORR: complete and partial response); tumor assessments by Computer Tomography (CT) scan or by Magnetic Resonance Imaging (MRI) [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Adverse events, laboratory parameters [ Time Frame: 3.5 years ] [ Designated as safety issue: No ]
  • Duration of response (DR); tumor assessments by CT scan or ba MRI [ Time Frame: from response to disease progression ] [ Designated as safety issue: No ]
  • Time to progression (TTP); tumor assessments by CT scan or by MRI [ Time Frame: from baseline to disease progression ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: from baseline to death of any cause ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: January 2006
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
5 mg/kg intravenously every 14 days
Drug: capecitabine [Xeloda]
1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle
Drug: oxaliplatin
40 mg/m2 iv weekly

  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
  • Locally advanced or metastatic colorectal cancer
  • No previous treatment with chemotherapy for metastatic disease
  • Measurable and/or evaluable lesions

Exclusion Criteria:

  • Radiotherapy within 4 weeks before study
  • Untreated brain metastases or primary brain tumors
  • Chronic, daily treatment with high-dose aspirin (>325mg/day)
  • Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159171

Locations
Italy
Aviano, Italy, 33081
Fano, Italy, 61032
Palermo, Italy, 90146
Rimini, Italy, 47900
Roma, Italy, 00135
Torino, Italy, 10126
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01159171     History of Changes
Other Study ID Numbers: ML18523
Study First Received: July 7, 2010
Last Updated: June 3, 2013
Health Authority: Italy: Italian Medicines Agency (AIFA)

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
Oxaliplatin
Capecitabine
 Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on June 13, 2013