A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer. - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00700102

Purpose

This study will evaluate the efficacy and safety of adding Avastin to crossover fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have experienced disease progression under first line treatment with standard chemotherapy plus Avastin. Patients will be randomized to one of 2 chemotherapy strata. Those in stratum 1 will receive chemotherapy (AIO-IRI, FOLFIRI, CAPIRI or XELIRI) alone, or in combination with Avastin (5mg/kg iv on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle) and those in stratum 2 will receive chemotherapy (FUFOX, FOLFOX, CAPOX or XELOX) alone, or in combination with Avastin (5mg/kg on days 1 and 14 of each 4 week cycle or 7.5mg/kg on days 1 and 22 of each 6 week cycle). The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: bevacizumab [Avastin] Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI Drug: FUFOX, FOLFOX, CAPOX or XELOX	Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Open-Label Study Phase III Intergroup Study: Effect of Adding Bevacizumab to Crossover Fluoropyrimidine Based Chemotherapy (CTx) in Patients With Metastatic Colorectal Cancer and Disease Progression Under First-Line Standard CTx/Bevacizumab Combination.

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Overall survival; response rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	820
Study Start Date:	September 2005
Estimated Study Completion Date:	May 2011

Arms	Assigned Interventions
1: Experimental	Drug: bevacizumab [Avastin] 5mg/kg iv on days 1 and 14 of each 4 week cycle, or 7.5mg/kg on days 1 and 22 of each 6 week cycle. Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI As prescribed
2: Experimental	Drug: bevacizumab [Avastin] 5mg/kg iv on days 1 and 14 of each 4 week cycle, or 7.5mg/kg on days 1 and 22 of each 6 week cycle. Drug: FUFOX, FOLFOX, CAPOX or XELOX As prescribed
3: Active Comparator	Drug: AIO-IRI, FOLFIRI, CAPIRI or XELIRI As prescribed
4: Active Comparator	Drug: FUFOX, FOLFOX, CAPOX or XELOX As prescribed

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;
metastatic colorectal cancer and disease progression, previously treated with first-line chemotherapy plus Avastin;
ECOG <=2.

Exclusion Criteria:

first line patients with progression-free survival in first line of <4 months;
other malignancies, except for curatively treated basal and squamous cell cancer of the skin or in situ cancer of the cervix;
clinically significant cardiovascular disease within 1 year of randomization;
CNS metastases.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700102

Contacts

Contact: Please reference Study ID Number: ML18147	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 153 Study Locations

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:	ML18147
Study First Received:	June 17, 2008
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00700102
Health Authority:	Germany: Ethics Commission

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Disease Progression
Gastrointestinal Neoplasms

Bevacizumab
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009