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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00118755
• Other study ID #: ML18491
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2005
• Last updated: February 9, 2011
• Start date: July 2005

Study information

• Verified date: February 2011
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 435
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	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).	Time to disease progression or death (through follow-up phase)	No
Secondary	Overall Survival	Overall survival was defined as the time from the date of randomization to the date of death, for any cause.	Time to death (through follow-up phase): Approximate Median of 718 days	No
Secondary	Best Overall Clinical Response	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.	Through follow-up phase: Approximate Median of 318 days	No
Secondary	Duration of Overall Clinical Response (CR or PR)	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.	Time to Disease Progression or Death (through follow-up phase): Approximate Median of 302 days	No

External Links

•   Clinical Study Report Synopsis