Trial information
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.
Status: Recruiting
Protocol number: ML20383
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label study to evaluate the effect of Avastin in association with chemotherapy on progression-free survival in patients with progressive advanced/metastatic well-differentiated digestive endocrine tumors of the gastrointestinal tract
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 digestive endocrine tumors. Patients with duodeno-pancreatic tumors (arm 1) will be treated with 5FU/streptozotocin iv (5FU 400mg/m2/d D1 to D5;streptozotocin 500mg/m2/d/iv D1 to D5;D1=D42) every 6 weeks, plus Avastin 7.5mg/kg iv every 3 weeks. Patients with gastrointestinal tract tumors (arm 2) will be treated with Xeloda 1000mg/m2 po bid D1 to D14 plus Avastin 7.5mg/kg iv D1=D21 every 3 weeks. The patients will be treated with chemotherapy for a minimum of 6 months, unless there is tumor progression and/or unacceptable toxicity. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals. Target sample size is 84.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Safety/Efficacy study
Condition: Neoplasms
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Median progression-free survival Time frame: Event driven
Key secondary outcomes: 1. Overall disease control rate, overall survival. Time frame: Event driven
2. AEs, SAEs. Time frame: Throughout study
Inclusion criteria:
- 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 criteria:
- 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).
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: June, 2007
Trial registration date: 03/19/2007
Date last updated: 8/29/2008
Link to trial result
This trial is being conducted at the following locations:
France
- Angers
- Bordeaux
- Boulogne-Billancourt
- Caen
- Chambray-Lès-Tours
- Clichy
- Creteil
- Dijon
- Lille
- Lyon
- Marseille
- Montpellier
- Nantes
- Nice
- Paris
- Poitiers
- Reims
- Rouen
- Saint Brieuc
- Strasbourg
- Toulouse
- Villejuif
