A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01131078
First received: April 20, 2010
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.


Condition Intervention Phase
Colorectal Cancer
Drug: bevacizumab [Avastin]
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: A Randomized, Open-label Study Comparing the Effect of 3 Chemotherapy Regimens Containing Avastin on Time to Disease Progression in Patients With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Time to progression\n [ Time Frame: From the first day of treatment until the first observation of disease progression, or death due to any cause (up to 5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From the first day of treatment until death due to any cause (up to 5 years) ] [ Designated as safety issue: No ]
  • Adverse events, laboratory parameters [ Time Frame: Throughout study or until early discontinuation (up to 5 years) ] [ Designated as safety issue: No ]

Enrollment: 306
Study Start Date: June 2005
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
1

  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;
  • colon or rectal cancer, with metastases;
  • >=1 measurable lesion.

Exclusion Criteria:

  • previous systemic treatment for advanced disease;
  • radiotherapy to any site within 4 weeks before study;
  • daily aspirin (>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration;
  • co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).
  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: NCT01131078

Locations
Italy
Paola, Calabria, Italy, 87027
Benevento, Campania, Italy, 82100
Napoli, Campania, Italy, 80136
Bologna, Emilia-Romagna, Italy, 40138
Carpi, Emilia-Romagna, Italy, 41012
Piacenza, Emilia-Romagna, Italy, 29100
Latisana, Friuli-Venezia Giulia, Italy, 33053
Udine, Friuli-Venezia Giulia, Italy, 33100
Latina, Lazio, Italy, 04100
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00186
Brescia, Lombardia, Italy, 25123
Busto Arsizio, Lombardia, Italy, 21052
Casalpusterlengo, Lombardia, Italy, 20071
Cremona, Lombardia, Italy, 26100
Gorgonzola, Lombardia, Italy, 20064
Lecco, Lombardia, Italy, 23900
Legnago, Lombardia, Italy, 37045
Mantova, Lombardia, Italy, 46100
Milano, Lombardia, Italy, 20121
Milano, Lombardia, Italy, 20142
Milano, Lombardia, Italy, 20133
Milano, Lombardia, Italy, 20162
Pavia, Lombardia, Italy, 27100
Saronno, Lombardia, Italy, 21047
Sondrio, Lombardia, Italy, 23100
Treviglio, Lombardia, Italy, 24047
Varese, Lombardia, Italy, 21100
Ancona, Marche, Italy, 60121
Novara, Piemonte, Italy, 28100
Torino, Piemonte, Italy, 10153
Cagliari, Sardegna, Italy, 09100
Catania, Sicilia, Italy, 95100
Palermo, Sicilia, Italy, 90127
Firenze, Toscana, Italy, 50139
Grosseto, Toscana, Italy, 58100
Pisa, Toscana, Italy, 56100
Prato, Toscana, Italy, 59100
Bolzano, Trentino-Alto Adige, Italy, 39100
Terni, Umbria, Italy, 05100
Camposampiero, Veneto, Italy, 35012
Este, Veneto, Italy, 35042
Montecchio Maggiore, Veneto, Italy, 36075
Negrar, Veneto, Italy, 37024
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: NCT01131078     History of Changes
Other Study ID Numbers: ML18524
Study First Received: April 20, 2010
Last Updated: March 3, 2014
Health Authority: ITALY: Agenzia Italiana del Farmaco

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 25, 2014