Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 1, 2010
Last updated: October 7, 2013
Last verified: October 2013

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Drug: eloxatin
Drug: capecitabine [Xeloda]
Drug: erlotinib [Tarceva]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label Study of the Effect of First-line Treatment With Avastin+Xelox, Followed by Avastin+Tarceva, on Progression-free Survival in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival\n [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate (ORR) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Incidence of adverse events (AEs) [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]
  • Abnormal laboratory values [ Time Frame: From study start up to approximately 4 years ] [ Designated as safety issue: No ]

Enrollment: 90
Study Start Date: November 2006
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
Intravenous repeating dose
Drug: eloxatin
Intravenous repeating dose
Drug: capecitabine [Xeloda]
Oral repeating dose
Drug: erlotinib [Tarceva]
Oral repeating dose


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

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • adenocarcinoma of colon or rectum, with metastatic disease;
  • >=1 measurable lesion.

Exclusion Criteria:

  • previous treatment with Avastin or Tarceva;
  • previous systemic treatment for advanced or metastatic disease;
  • adjuvant treatment for non-metastatic disease in past 6 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01135498

Sabadell, Barcelona, Barcelona, Spain, 08208
Terrassa, Barcelona, Spain, 08221
Santander, Cantabria, Spain, 39008
Palma de Mallorca, Islas Baleares, Spain, 07198
Logroño, La Rioja, Spain, 26006
Barakaldo, Vizcaya, Spain, 48903
Burgos, Spain, 09006
Huesca, Spain, 22004
Jaen, Spain, 23007
Lerida, Spain, 25198
Teruel, Spain, 44002
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01135498     History of Changes
Other Study ID Numbers: ML19875
Study First Received: June 1, 2010
Last Updated: October 7, 2013
Health Authority: Spain: Ministry of Health and Consumption

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses processed this record on November 20, 2014