AXEL Study: An Observational Study of First-Line Xeloda (Capecitabine) Based Chemotherapy With or Without Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer

This study is currently recruiting participants.
Verified March 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01696695
First received: September 27, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

This observational study will evaluate the efficacy and safety of different Xeloda (capecitabine) based chemotherapies, alone or in combination with Avastin (bevacizumab), in first line in patients with metastatic colorectal cancer.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival with different Xeloda-based chemotherapy regimens [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate (complete response + partial response) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate (complete response + partial response + stable disease) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Metastasectomy rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Mean duration of Xeloda treatment [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Dose modification rate for Xeloda [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with newly diagnosed colorectal cancer who have started first-line capecitabine (Xeloda) based chemotherapy alone or in combination with bevacizumab (Avastin)

Criteria

Inclusion Criteria:

  • Patients with newly diagnosed metastatic colorectal cancer who have started first-line Xeloda-based chemotherapy in accordance with the current Hungarian label

Exclusion Criteria:

  • History of serious or unexpected reaction to fluoropyrimidine therapy
  • Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
  • Known dihydropyrimidine dehydrogenase deficiency
  • Pregnancy or lactation
  • Inadequate bone marrow, hepatic or renal function
  • Treatment with sorivudine or its chemical analogues (e.g. brivudine)
  • If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01696695

Contacts
Contact: Reference Study ID Number: ML27791 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Hungary
Recruiting
Budapest, Hungary, 1032
Recruiting
Budapest, Hungary, 1076
Recruiting
Budapest, Hungary, 1088
Recruiting
Budapest, Hungary, 1125
Recruiting
Budapest, Hungary, 1145
Recruiting
Debrecen, Hungary, 4031
Recruiting
Gyor, Hungary, 9024
Recruiting
Gyula, Hungary, 5700
Recruiting
Kecskemet, Hungary, 6000
Recruiting
Kistarcsa, Hungary, 2143
Recruiting
Miskolc, Hungary, 3501
Active, not recruiting
Nyíregyháza, Hungary, 4400
Active, not recruiting
Pecs, Hungary, 7624
Recruiting
Salgótarján, Hungary, 3100
Recruiting
Szeged, Hungary, 6701
Active, not recruiting
Szekesfehervar, Hungary, 8000
Recruiting
Szekszard, Hungary, 7100
Recruiting
Szentes, Hungary, 6600
Recruiting
Szombathely, Hungary, 9700
Recruiting
Tatabanuya, Hungary, 2800
Recruiting
Veszprem, Hungary, 8200
Recruiting
Zalaegerszeg, Hungary, 8900
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01696695     History of Changes
Other Study ID Numbers: ML27791
Study First Received: September 27, 2012
Last Updated: March 31, 2014
Health Authority: Hungary: National Instutute of Pharmacy

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
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014