A Study of Avastin (Bevacizumab) in Patients With Newly Diagnosed Locally Advanced Rectal Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00865189

Purpose

This study will assess the efficacy and safety of two different neoadjuvant treatment approaches including Avastin in newly diagnosed patients with high risk locally advanced rectal cancer. Patients will be randomized into one of two treatment arms. Arm A will undergo an induction phase, consisting of 6 cycles of Avastin (5mg/kg iv) plus FOLFOX 4, followed by a 7 week chemoradiation phase, consisting of Avastin (5mg/kg iv) plus 5-FU plus radiotherapy, followed by surgery. Arm B will omit the induction phase, but will undergo the chemoradiation phase followed by surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: bevacizumab [Avastin]	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer Radiation Therapy

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Open-Label Study to Assess the Effect on Tumor Response, and the Safety, of Two Neo-Adjuvant Approaches With Avastin in Newly-Diagnosed Patients With High Risk Locally-Advanced Rectal Cancer

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Rate of sterilisation of tumoral specimen: YpT0-N0 [ Time Frame: After surgery (6-8 weeks after chemoradiation) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Efficacy: Compliance, pathological tumor downstaging rate, recurrence rates, disease free survival, overall survival. Safety: AEs, SAEs, lab parameters, post-operative complications. [ Time Frame: Efficacy:event driven (throughout study) Safety:at each clinic visit throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	91
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2010

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 6x2 week cycles of 5mg/kg iv + FOLFOX, followed by 4x2 week cycles of 5mg/kg iv + 5-FU + radiotherapy
2: Experimental	Drug: bevacizumab [Avastin] 4 x 2 week cycles of 5mg/kg iv + 5-FU + radiotherapy

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

adult patients, 18-75 years of age;
histologically confirmed locally advanced rectal cancer;
measurable disease;
ECOG performance status 0-1;
no prior chemotherapy or radiation therapy for rectal cancer.

Exclusion Criteria:

prior treatment with Avastin;
prior radiotherapy to pelvic region, or previous cytotoxic chemotherapy;
previous history of malignancy (other than basal and squamous cell cancer of the skin, or in situ cancer of the cervix);
history or evidence of CNS disease;
clinically significant cardiovascular disease;
chronic treatment with high dose aspirin (>325mg/day) or NSAID.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00865189

Contacts

Contact: Please reference Study ID Number: ML19202	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

France
	Recruiting
BESANCON, France, 25030
	Recruiting
DIJON, France, 21000
	Recruiting
PIERRE BENITE, France, 69310
	Recruiting
MONTPELLIER, France, 34928
	Not yet recruiting
AVIGNON, France, 84082
	Recruiting
TOURS, France, 37044
	Not yet recruiting
SAINT HERBLAIN, France, 44805
	Recruiting
STRASBOURG, France, 67065
	Recruiting
LILLE, France, 59020
	Not yet recruiting
BORDEAUX, France, 33076
	Not yet recruiting
VILLEJUIF, France, 94805
	Recruiting
VANDOEUVRE-LES-NANCY, France, 54511
	Recruiting
PARIS, France, 75970
	Recruiting
PARIS, France, 75475
	Recruiting
POITIERS, France, 86021
	Not yet recruiting
STRASBOURG, France, 67085
	Recruiting
BORDEAUX, France, 33075
	Recruiting
MONTBELIARD, France, 25209
	Not yet recruiting
SAINT-PRIEST-EN-JAREZ, France, 42270
	Recruiting
TOULOUSE, France, 31078
	Recruiting
PARIS, France, 75651
	Not yet recruiting
ANNECY, France, 74000
	Not yet recruiting
ANGERS, France, 49033
	Recruiting
NICE, France, 06189
	Recruiting
NANCY, France, 54100
	Not yet recruiting
CLICHY, France, 92118
	Recruiting
LA TRONCHE, France, 38700

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Chair:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML19202
Study First Received:	March 18, 2009
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00865189 History of Changes
Health Authority:	France:AFSSAPS

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Adjuvants, Immunologic
Rectal Neoplasm
Bevacizumab
Intestinal Diseases
Angiogenesis Inhibitors

Rectal Diseases
Intestinal Neoplasms
Oxymetazoline
Digestive System Diseases
Rectal Cancer
Phenylephrine
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Antineoplastic Agents
Rectal Neoplasms
Gastrointestinal Diseases
Growth Substances
Physiological Effects of Drugs
Colonic Diseases
Bevacizumab
Intestinal Diseases
Angiogenesis Inhibitors
Rectal Diseases

Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Growth Inhibitors
Angiogenesis Modulating Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009