A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum.
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01169558
First received: July 22, 2010
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This expanded access study will assess the efficacy and safety of intravenous Avastin (5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks) in combination with fluoropyrimidine-based chemotherapy as first line treatment of patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is 3-12 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: bevacizumab [Avastin] |
Phase 3 |
| 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 Expanded Access Program of Avastin in Patients With Metastatic Cancer of Colon or Rectum - Brazilian Extension Study |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Safety: Serious and specific adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Efficacy: Duration of survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Efficacy: Time to disease progression [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 163 |
| Study Start Date: | May 2006 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to chemotherapy regimen
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Previously untreated metastatic colon or rectal cancer;
- Scheduled to begin fluoropyrimidine-based chemotherapy as a first line treatment.
Exclusion Criteria:
- Prior chemotherapy for metastatic colon or rectal cancer;
- Planned radiotherapy for underlying disease;
- central nervous system metastases;
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before study start.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169558
Locations
| Brazil | |
| Belo Horizonte, Brazil, 30140-083 | |
| Belo Horizonte, Brazil, 30150321 | |
| Brasilia, Brazil, 70710-904 | |
| Brasilia, Brazil, 70390-150 | |
| Campinas, Brazil, 13084-759 | |
| Campinas, Brazil, 13073-400 | |
| Caxias Do Sul, Brazil, 95020-450 | |
| Curitiba, Brazil, 80530-010 | |
| Curitiba, Brazil, 80730-180 | |
| Fortaleza, Brazil, 60741-420 | |
| Ijui, Brazil, 98700-000 | |
| Joao Pessoa, Brazil, 58040280 | |
| Porto Alegre, Brazil, 90020-090 | |
| Porto Alegre, Brazil, 90035-903 | |
| Recife, Brazil, 52012-220 | |
| Ribeirao Preto, Brazil, 14025-430 | |
| Rio de Janeiro, Brazil, 22631-004 | |
| Rio de Janeiro, Brazil, 22031072 | |
| Salvador, Brazil, 40170-110 | |
| Salvador, Brazil, 41810-012 | |
| Salvador, Brazil, 41950-610 | |
| Sao Paulo, Brazil, 04122-000 | |
| Sao Paulo, Brazil, 01406-000 | |
| Sao Paulo, Brazil, 05651-901 | |
| Sao Paulo, Brazil, 01232-010 | |
| Sao Paulo, Brazil, 01332-000 | |
| Sao Paulo, Brazil, 01229-000 | |
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: | NCT01169558 History of Changes |
| Other Study ID Numbers: | ML20552 |
| Study First Received: | July 22, 2010 |
| Last Updated: | June 3, 2013 |
| Health Authority: | Brazil: National Health Surveillance Agency |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Neoplasm Metastasis Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases |
Rectal Diseases Neoplastic Processes Pathologic Processes 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 June 17, 2013