Status:
COMPLETED
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This 2 arm study will assess the efficacy and safety of two systemic treatments including Avastin in patients with previously-untreated progressive locally advanced/metastatic well-differentiated dige...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- well-differentiated gastrointestinal tract endocrine tumors, or duodeno-pancreatic endocrine tumors;
- no previous anti-cancer therapy, other than surgery;
- progressive metastatic disease;
- \>=1 measurable lesion.
Exclusion
- abnormal cardiac function, with history of ischemic heart disease in past 6 months and/or abnormal 12 lead ECG;
- patients with known bleeding disorders;
- unstable systemic disease;
- chronic daily treatment with high-dose aspirin, NSAIDs or corticosteroids;
- previous history of malignancy (other than successfully treated basal and squamous cell cancer of the skin, and/or in situ cancer of the cervix).
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00448136
Start Date
July 1 2007
End Date
November 1 2011
Last Update
January 22 2015
Active Locations (27)
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1
Angers, France, 49933
2
Bordeaux, France, 33075
3
Boulogne-Billancourt, France, 92104
4
Caen, France, 14033