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

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: capecitabine; Drug: Oxaliplatin; Drug: bevacizumab	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	435 participants
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
Study Start Date :	July 2005
Actual Primary Completion Date :	April 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

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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

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Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:	Clinical Trials	Hoffmann-La Roche

More Information

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Additional Information:

Clinical Study Report Synopsis 

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00118755 History of Changes
Other Study ID Numbers:	ML18491
First Posted:	July 12, 2005
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