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A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00642603
Recruitment Status : Terminated
First Posted : March 25, 2008
Results First Posted : June 23, 2011
Last Update Posted : March 29, 2018
Sponsor:
Information provided by:
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 25, 2008
Results First Submitted Date  ICMJE June 10, 2010
Results First Posted Date  ICMJE June 23, 2011
Last Update Posted Date March 29, 2018
Study Start Date  ICMJE May 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2011)
Progression-free Survival (PFS) in U.S. Patients Only [ Time Frame: From first patient enrolled up to approximately 48 months ]
PFS was defined as the time from the date of randomization to the first documented occurrence of disease progression or death due to any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
Progression-free survival [ Time Frame: Event driven ]
Change History Complete list of historical versions of study NCT00642603 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • Overall response rate, overall survival, time to response, duration of overall response, time to progression, time to treatment failure, rate of completion of 9 cycles of triple-drug therapy, rate of surgical intervention. [ Time Frame: Event driven ]
  • Progression-free survival rates [ Time Frame: 6, 9 and 12 months ]
  • Adverse events, laboratory parameters. [ Time Frame: Throughout study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Xeloda (Capecitabine) in Combination With Avastin + Short Course Chemotherapy in Patients With Metastatic Colorectal Cancer
Official Title  ICMJE A Randomized, Open Label Study of the Effect of First Line Treatment With Xeloda in Combination With Avastin and Either Short Course Irinotecan or Short Course Oxaliplatin on Progression-free Survival in Patients With Metastatic Colorectal Cancer
Brief Summary This 2-arm study was designed to evaluate the efficacy and safety of 2 treatment regimens of Xeloda and Avastin, with either irinotecan or oxaliplatin administered for the first 12 cycles, as first line treatment in patients with metastatic colorectal cancer. Patients were randomized to receive 2-weekly cycles of treatment with either: 1) Xeloda, Avastin and oxaliplatin; or 2) Xeloda, Avastin and irinotecan. After 9 cycles, patients continued to receive maintenance treatment with Xeloda + Avastin. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: capecitabine [Xeloda]
    1000 mg/m2 twice-daily, taken orally on Days 1-7 of each 2 week cycle
  • Drug: bevacizumab [Avastin]
    5 mg/kg taken intravenously on Day 1 of each 2 week cycle
  • Drug: oxaliplatin
    85 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
  • Drug: irinotecan
    135 mg/m2 taken intravenously on Day 1 of each 2 week cycle, for first 9 cycles
Study Arms  ICMJE
  • Experimental: XELOX + bevacizumab (Q2W)
    Interventions:
    • Drug: capecitabine [Xeloda]
    • Drug: bevacizumab [Avastin]
    • Drug: oxaliplatin
  • Experimental: XELIRI + bevacizumab (Q2W)
    Interventions:
    • Drug: capecitabine [Xeloda]
    • Drug: bevacizumab [Avastin]
    • Drug: irinotecan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 31, 2011)
41
Original Estimated Enrollment  ICMJE
 (submitted: March 19, 2008)
230
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult patients, ≥18 years of age
  • Histologically confirmed adenocarcinoma of colon or rectum, with unresectable metastatic or locally advanced disease
  • ≥1 measurable target lesion
  • Ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Exclusion Criteria:

  • Prior systemic therapy for advanced or metastatic disease
  • History of another malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of the cervix
  • Clinically significant cardiovascular disease
  • Current or recent use of full dose oral warfarin or full dose parenteral anticoagulants or thrombolytic agents
  • Chronic daily treatment with >325 mg/day aspirin
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Canada
 
Administrative Information
NCT Number  ICMJE NCT00642603
Other Study ID Numbers  ICMJE ML21567
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Disclosures Group, Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date February 2018

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