A Study of Avastin (Bevacizumab) in Combination 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:
NCT01131078
First received: April 20, 2010
Last updated: March 11, 2013
Last verified: March 2013
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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: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bevacizumab [Avastin]
1
Other Name: Avastin
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131078
Locations
| Italy | |
| Ancona, Italy, 60121 | |
| Benevento, Italy, 82100 | |
| Bologna, Italy, 40138 | |
| Bolzano, Italy, 39100 | |
| Brescia, Italy, 25123 | |
| Busto Arsizio, Italy, 21052 | |
| Cagliari, Italy, 09100 | |
| Camposampiero, Italy, 35012 | |
| Carpi, Italy, 41012 | |
| Casalpusterlengo, Italy, 20071 | |
| Catania, Italy, 95100 | |
| Cremona, Italy, 26100 | |
| Este, Italy, 35042 | |
| Firenze, Italy, 50139 | |
| Gorgonzola, Italy, 20064 | |
| Grosseto, Italy, 58100 | |
| Latina, Italy, 04100 | |
| Latisana, Italy, 33053 | |
| Lecco, Italy, 29300 | |
| Legnago, Italy, 37045 | |
| Mantova, Italy, 46100 | |
| Milano, Italy, 20133 | |
| Milano, Italy, 20142 | |
| Milano, Italy, 20162 | |
| Milano, Italy, 20121 | |
| Montecchio Maggiore, Italy, 36075 | |
| Napoli, Italy, 80136 | |
| Negrar, Italy, 37024 | |
| Novara, Italy, 28100 | |
| Palermo, Italy, 90127 | |
| Paola, Italy, 87027 | |
| Pavia, Italy, 27100 | |
| Piacenza, Italy, 29100 | |
| Pisa, Italy, 56100 | |
| Prato, Italy, 59100 | |
| Roma, Italy, 00186 | |
| Roma, Italy, 00168 | |
| Saronno, Italy, 21047 | |
| Sondrio, Italy, 23100 | |
| Terni, Italy, 05100 | |
| Torino, Italy, 10153 | |
| Treviglio, Italy, 24047 | |
| Udine, Italy, 33100 | |
| Varese, Italy, 21100 | |
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 11, 2013 |
| 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 May 16, 2013