Phase II Study in Colorectal Cancer - Full Text View

Sponsored by:	Universitaire Ziekenhuizen Leuven
Information provided by:	Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT00828672

Purpose

Phase II clinical trial, open-label, randomized, two arms, multicentre (possibly multinational). Academic, investigator initiated.

To assess the activity of bevacizumab (AvastinTM) in combination with capecitabine (XelodaTM) and radiation therapy with or without oxaliplatin (EloxatinTM) in the pre-operative treatment of locally advanced rectal cancer, followed by TME (total mesorectal excision).

Condition	Intervention	Phase
Advanced Colorectal Cancer	Drug: Oxaliplatin Drug: Bevacizumab Drug: Capecitabine Radiation: radiotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Phase II Study of Bevacizumab, Capecitabine and Radiation Therapy With or Without Oxaliplatin in the Preoperative Treatment of Locally Advanced Rectal Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer Radiation Therapy

Drug Information available for: Oxaliplatin Capecitabine Bevacizumab

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

Pathologic complete response (ypT0N0) rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Histopathologic R0 and negative CRM resection rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Pathologic downstaging (yp T0-2 N0) rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Tumor regression grade [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Clinical response rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: continuous up to 1 year ] [ Designated as safety issue: Yes ]
Loco-regional and distant recurrence rates [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Progression-free and overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Oxaliplatin, Bevacizumab and Capecitabine concurrently with radiotherapy.	Drug: Oxaliplatin Drug: Bevacizumab Drug: Capecitabine Radiation: radiotherapy
2: Active Comparator Bevacizumab and Capecitabine concurrently with radiotherapy	Drug: Bevacizumab Drug: Capecitabine Radiation: radiotherapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient is at least 18 years of age
Good organ function
Locally advanced (according to RECIST criteria) adenocarcinoma of the rectum

Exclusion Criteria:

Evidence of distant metastases
Contraindication for bevacizumab
Pregnant or breastfeeding women.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00828672

Contacts

Contact: Eric Van Cutsem, Prof. Dr	016/344.418	eric.vancutsem@uz.kuleuven.ac.be
Contact: Karin Haustermans, Prof.Dr		karin.haustermans@uz.kuleuven.ac.be

Locations

Belgium
Erasme Hospital
Brussels, Belgium, 1070
Cliniques Universitaires St Luc
Brussels, Belgium, 1200
AZ St- Lucas
Brugge, Belgium, 8310
AZ Sint-Jan
Brugge, Belgium, 8000
AZ Groeninge
Kortrijk, Belgium, 8500
C.H.U. Sart-Tilman
Liege, Belgium, 4000
Salvator Ziekenhuis
Hasselt, Belgium, 3500
Onze Lieve Vrouwziekenhuis
Aalst, Belgium, 9300
ZNA Middelheim
Antwerp, Belgium, ZNA Middelheim
H. Hartziekenhuis
Roeselare, Belgium, 8800
Clinique Sainte Elisabeth
Namur, Belgium, 5000
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, Belgium, 2610

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators

Principal Investigator:

Eric Van Cutsem, Prof. Dr.

UZ Leuven

More Information

No publications provided

Responsible Party:	UZ Leuven ( Prof. Dr. Eric Van Cutsem )
Study ID Numbers:	s51104 - ML5194, 2007 - 007177 - 23, MO19051
Study First Received:	January 23, 2009
Last Updated:	January 23, 2009
ClinicalTrials.gov Identifier:	NCT00828672 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:

assess activity
bevacizumab
capecitabine
radiation therapy

oxaliplatin
pre-operative treatment
TME (total mesorectal excision).

Study placed in the following topic categories:

Antimetabolites
Capecitabine
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Rectal Neoplasm
Bevacizumab
Intestinal Diseases

Angiogenesis Inhibitors
Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Bevacizumab
Rectal Diseases
Oxaliplatin
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents

Growth Inhibitors
Capecitabine
Digestive System Neoplasms
Growth Substances
Intestinal Diseases
Angiogenesis Inhibitors
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009