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:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00118755
First received: July 1, 2005
Last updated: February 9, 2011
Last verified: February 2011

July 1, 2005
February 9, 2011
July 2005
April 2009   (final data collection date for primary outcome measure)
Progression-free Survival (PFS) [ Time Frame: Time to disease progression or death (through follow-up phase) ] [ Designated as safety issue: No ]
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).
Not Provided
Complete list of historical versions of study NCT00118755 on ClinicalTrials.gov Archive Site
  • Overall Survival [ Time Frame: Time to death (through follow-up phase): Approximate Median of 718 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
A Study of Two Different Schedules of Xeloda (Capecitabine) as First Line Therapy in Patients With Metastatic Colorectal Cancer
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • 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
  • 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
  • Experimental: 1
    Interventions:
    • Drug: capecitabine
    • Drug: Oxaliplatin
    • Drug: bevacizumab
  • Active Comparator: 2
    Interventions:
    • Drug: capecitabine
    • Drug: Oxaliplatin
    • Drug: bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
435
Not Provided
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00118755
ML18491
Not Provided
Disclosures Group, Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP