A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Previously Untreated Metastatic Colorectal Cancer.

This study has been terminated.
Sponsor:
Collaborator:
Merck KGaA
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00577109
First received: December 18, 2007
Last updated: June 17, 2008
Last verified: June 2008
  Purpose

This single arm study will assess the efficacy and safety of a combination of modified FOLFIRI (irinotecan, 5-FU and leucovirin), Avastin and cetuximab in patients with previously untreated metastatic colorectal cancer. Patients will receive modified FOLFIRI (irinotecan 180mg/m2 iv, leucovirin 200mg/m2 iv, and 5-FU 400mg/m2 iv) on day 1 of each 2 week cycle, in combination with Avastin (5mg/kg iv on day 1 of each cycle) and cetuximab (loading dose of 400mg/m2 followed by 250mg/m2 on day 3 of each cycle). The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
Drug: Irinotecan
Drug: Leucovorin
Drug: 5 FU
Drug: Cetuximab
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: An Open Label Study to Assess the Effect of FOLFIRI Plus Avastin and Cetuximab on Progression-Free Survival in Patients With Previously Untreated Metastatic Colorectal Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate, rate of resection of hepatic metastases, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Estimated Study Completion Date: June 2012
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
5mg/kg iv on day 1 of each 2 week cycle
Drug: Irinotecan
180mg/m2 iv on day 1 of each 2 week cycle
Drug: Leucovorin
200mg/m2 iv on day 1 of each 2 week cycle
Drug: 5 FU
400mg/m2 iv on day 1 of each 2 week cycle
Drug: Cetuximab
Loading dose of 400mg/m2 iv followed by 250mg/m2 iv on day 3 of each 2 week cycle

  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;
  • colorectal cancer;
  • advanced or recurrent disease;
  • >=1 measurable lesion;
  • >=6 months since prior adjuvant therapy, and >=4 weeks since prior radiotherapy.

Exclusion Criteria:

  • previous treatment for colorectal cancer;
  • significant history of cardiac disease in past 6 months;
  • other invasive malignancy within past 5 years, except for nonmelanoma skin cancer, and successfully treated cervical or prostate cancer.
  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 ClinicalTrials.gov identifier: NCT00577109

Locations
Brazil
Salvador, Brazil
Sao Paulo, Brazil
Sorocaba, Brazil
Sponsors and Collaborators
Hoffmann-La Roche
Merck KGaA
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Clinical Trials, Study Director, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00577109     History of Changes
Other Study ID Numbers: ML20452
Study First Received: December 18, 2007
Last Updated: June 17, 2008
Health Authority: Brazil: Comissao Nacional de Etica em Pesquisa (CONEP)

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
Leucovorin
Bevacizumab
Levoleucovorin
Irinotecan
Cetuximab
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014