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

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: capecitabine; Drug: Oxaliplatin; Drug: bevacizumab

• Registration Number: NCT00118755
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07
• Study First Submitted: 2005-07-01
• Study First Submitted QC: 2005-07-11
• Study First Posted: 2005-07-12
• Primary Completion: 2009-04
• Results First Submitted: 2010-04-25
• Status Verified: 2011-02
• Results First Submitted QC: 2011-02-09
• Last Update Submitted: 2011-02-09
• Results First Posted: 2011-03-03
• Last Update Posted: 2011-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	capecitabine	-
2	Oxaliplatin	-
2	bevacizumab	-
1	capecitabine	-
1	Oxaliplatin	-
1	bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS)	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

Name	Time	Method
Overall Survival	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	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 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.