A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Endocrine Tumors of the Gastrointestinal Tract.

NCT ID: NCT00448136

Last Updated: 2015-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2011-11-30

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.

Conditions

Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

7.5mg/kg iv on day 1 every 3 weeks

5 FU

Intervention Type: DRUG

400mg/m2/day iv on days 1-5 every 6 weeks

Streptozotocin

Intervention Type: DRUG

500mg/m2/day iv on days 1-5 every 6 weeks

2

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

7.5mg/kg iv on day 1 every 3 weeks

Xeloda

Intervention Type: DRUG

1000mg/m2 po bid on days 1-14 every 3 weeks

Interventions

bevacizumab [Avastin]

7.5mg/kg iv on day 1 every 3 weeks

Intervention Type: DRUG

5 FU

400mg/m2/day iv on days 1-5 every 6 weeks

Intervention Type: DRUG

Streptozotocin

500mg/m2/day iv on days 1-5 every 6 weeks

Intervention Type: DRUG

Xeloda

1000mg/m2 po bid on days 1-14 every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Angers, , France

Bordeaux, , France

Boulogne-Billancourt, , France

Caen, , France

Chambray-lès-Tours, , France

Clichy, , France

Créteil, , France

Dijon, , France

Lille, , France

Lyon, , France

Marseille, , France

Marseille, , France

Marseille, , France

Montpellier, , France

Nantes, , France

Nice, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Poitiers, , France

Reims, , France

Rouen, , France

Saint-Brieuc, , France

Strasbourg, , France

Toulouse, , France

Villejuif, , France

Countries

France

Other Identifiers

ML20383

Identifier Type: -

Identifier Source: org_study_id