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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00448136

Purpose

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.

Condition	Intervention	Phase
Neoplasms	Drug: bevacizumab [Avastin] Drug: 5 FU Drug: Streptozotocin Drug: Xeloda	Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Capecitabine Bevacizumab Fluorouracil Streptozocin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official 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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Median progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall disease control rate, overall survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, SAEs. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2011

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 7.5mg/kg iv on day 1 every 3 weeks Drug: 5 FU 400mg/m2/day iv on days 1-5 every 6 weeks Drug: Streptozotocin 500mg/m2/day iv on days 1-5 every 6 weeks
2: Experimental	Drug: bevacizumab [Avastin] 7.5mg/kg iv on day 1 every 3 weeks Drug: Xeloda 1000mg/m2 po bid on days 1-14 every 3 weeks

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;
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00448136

Contacts

Contact: Please reference Study ID Number: ML20383	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Recruiting
BOULOGNE-BILLANCOURT, France, 92104
	Terminated
PARIS, France, 75970
	Recruiting
LILLE, France, 59020
	Recruiting
VILLEJUIF, France, 94805
	Recruiting
NICE, France, 06189
	Recruiting
CAEN, France, 14033
	Recruiting
ANGERS, France, 49033
	Recruiting
TOULOUSE, France, 31052
	Recruiting
STRASBOURG, France, 67098 CEDE
	Recruiting
PARIS, France, 75571
	Recruiting
ROUEN, France, 76031
	Recruiting
MARSEILLE, France, 13005
	Recruiting
BORDEAUX, France, 33000
	Not yet recruiting
MARSEILLE, France, 13273
	Recruiting
NANTES, France, 44035
	Recruiting
REIMS, France, 51092
	Recruiting
PARIS, France, 75651
	Recruiting
CHAMBRAY-LÈS-TOURS, France, 37044
	Recruiting
POITIERS, France, 86021
	Recruiting
DIJON, France, 21079
	Recruiting
CRETEIL, France, 94010
	Recruiting
CLICHY, France, 92118
	Recruiting
LYON, France, 69437
	Recruiting
MARSEILLE, France, 13285
	Recruiting
SAINT BRIEUC, France, 22000
	Not yet recruiting
PARIS, France, 75908
	Recruiting
MONTPELLIER, France, 34298

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20383
Study First Received:	March 15, 2007
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00448136
Health Authority:	France: AFSSAPS (Agence francaise de securite sanitaire des produits de sante)

Study placed in the following topic categories:

Capecitabine
Fluorouracil
Disease Progression
Endocrine System Diseases

Bevacizumab
Endocrinopathy
Streptozocin
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009