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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
History of Changes
  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:

U.S. FDA Resources

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
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 May 23, 2013