A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00118755

Purpose

This 2 arm study will evaluate the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous Eloxatin (oxaliplatin) and intravenous bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients will be randomized to receive either 1)Xeloda 850mg/m2 po bid on days 1-14, oxaliplatin 130mg/m2 iv on day 1, and Avastin 7.5mg/kg iv on day 1 of each 3 week cycle or 2)Xeloda 1500mg/m2 po bid on days 1-7, oxaliplatin 85mg/m2 iv on day 1 and Avastin 5mg/kg iv on day 1 of each 2 week cycle. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine [Xeloda] Drug: Oxaliplatin Drug: Avastin	Phase IV

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Capecitabine Bevacizumab Oxaliplatin

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 of the Effect of 2 Different Treatment Schedules of Xeloda With Eloxatin and Avastin on Progression-Free Survival in Treatment-naïve Patients With Locally Advanced or Metastatic Colorectal Cancer

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Overall response rate, survival time, duration of response, time to treatment failure, rate of complete surgical resection. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
QoL, AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	430
Study Start Date:	July 2005
Estimated Study Completion Date:	October 2009

Arms	Assigned Interventions
1: Experimental	Drug: capecitabine [Xeloda] 850mg/m2 po bid on days 1-14 of each 3 week cycle Drug: Oxaliplatin 130mg/m2 iv on day 1 of each 3 week cycle Drug: Avastin 7.5mg/kg iv on day 1 of each 3 week cycle
2: Active Comparator	Drug: capecitabine [Xeloda] 1500mg/m2 po bid on days 1-7 of each 2 week cycle Drug: Oxaliplatin 85mg/m2 iv on day 1 of each 2 week cycle Drug: Avastin 5mg/kg iv on day 1 of each 2 week cycle

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 or inoperable locally advanced colorectal cancer;
>=1 measurable target lesion.

Exclusion Criteria:

previous systemic therapy for advanced or metastatic disease;
previous treatment with bevacizumab.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118755

Show 157 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:	ML18491
Study First Received:	July 1, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00118755
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Disease Progression
Bevacizumab
Intestinal Diseases

Rectal Diseases
Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009