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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00118755

First Posted: July 12, 2005

Last Update Posted: March 3, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Hoffmann-La Roche

Purpose

This 2-arm study evaluated the efficacy and safety of 2 different treatment schedules of oral Xeloda with intravenous (IV) Eloxatin (oxaliplatin) and IV bevacizumab (Avastin) as a first-line treatment in patients with locally advanced or metastatic colorectal cancer. Patients were randomized to receive either: 1) Xeloda 850 mg/m^2 orally twice a day (po bid) on Days 1-14, oxaliplatin 130 mg/m^2 IV on Day 1, and Avastin 7.5 mg/kg IV on Day 1 of each 3-week cycle; or 2) Xeloda 1500 mg/m^2 po bid on Days 1-7, oxaliplatin 85 mg/m^2 IV on Day 1 and Avastin 5 mg/kg IV on Day 1 of each 2-week cycle. The anticipated time on study treatment was 1-2 years, and the target sample size was 100-500 individuals.

Condition	Intervention	Phase
Colorectal Cancer	Drug: capecitabine Drug: Oxaliplatin Drug: bevacizumab	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free Survival (PFS) [ Time Frame: Time to disease progression or death (through follow-up phase) ]
Progression-free survival was defined as the time from the date of randomization to the first occurrence of having documented disease progression or death due to any cause, whichever comes first. Progression was based on tumor assessments made by the investigators according to Response Evaluation Criteria in Solid Tumors (RECIST).

Secondary Outcome Measures:

Overall Survival [ Time Frame: Time to death (through follow-up phase): Approximate Median of 718 days ]
Overall survival was defined as the time from the date of randomization to the date of death, for any cause.
Best Overall Clinical Response [ Time Frame: Through follow-up phase: Approximate Median of 318 days ]
Overall response rate was assessed according to RECIST (the best response recorded from the time of randomization to the first CR or PR. The patient's overall best response was complete response (CR), partial response (PR) (CR and PR considered "responders"), stable disease (SD), or progressive disease (PD). To be assigned a status of complete response (CR) or partial response (PR), changes in tumor measurements were confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met.
Duration of Overall Clinical Response (CR or PR) [ Time Frame: Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days ]
Among tumor responders (i.e., patients with overall best response of CR or PR), duration of overall response was measured from the time criteria were first met for CR or PR (whichever status was recorded first) to the date of either recurrent/progressive disease was objectively documented or death from any cause.


Enrollment:	435
Study Start Date:	July 2005
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: capecitabine 850 mg/m^2 po bid on Days 1-14 of each 3-week cycle Drug: Oxaliplatin 130 mg/m^2 IV on Day 1 of each 3-week cycle Drug: bevacizumab 7.5 mg/kg IV on Day 1 of each 3-week cycle
Active Comparator: 2	Drug: capecitabine 1500 mg/m^2 po bid on Days 1-7 of each 2-week cycle Drug: Oxaliplatin 85 mg/m^2 IV on Day 1 of each 2-week cycle Drug: bevacizumab 5 mg/kg IV on Day 1 of each 2-week cycle

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118755

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

Additional Information:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site


Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00118755 History of Changes
Other Study ID Numbers:	ML18491
First Submitted:	July 1, 2005
First Posted:	July 12, 2005
Results First Submitted:	April 25, 2010
Results First Posted:	March 3, 2011
Last Update Posted:	March 3, 2011
Last Verified:	February 2011

Additional relevant MeSH terms:


Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Bevacizumab	Oxaliplatin Capecitabine Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action

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