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

NCT ID: NCT01135498

Last Updated: 2015-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-04-30

Brief Summary

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

Intravenous repeating dose

eloxatin

Intervention Type: DRUG

Intravenous repeating dose

capecitabine [Xeloda]

Intervention Type: DRUG

Oral repeating dose

erlotinib [Tarceva]

Intervention Type: DRUG

Oral repeating dose

Interventions

bevacizumab [Avastin]

Intravenous repeating dose

Intervention Type: DRUG

eloxatin

Intravenous repeating dose

Intervention Type: DRUG

capecitabine [Xeloda]

Oral repeating dose

Intervention Type: DRUG

erlotinib [Tarceva]

Oral repeating dose

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Palma de Mallorca, Balearic Islands, Spain

Sabadell, Barcelona, Barcelona, Spain

Terrassa, Barcelona, Spain

Burgos, Burgos, Spain

Santander, Cantabria, Spain

Huesca, Huesca, Spain

Jaén, Jaen, Spain

Logroño, La Rioja, Spain

Lleida, Lerida, Spain

Teruel, Teruel, Spain

Barakaldo, Vizcaya, Spain

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

ML19875

Identifier Type: -

Identifier Source: org_study_id