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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01696695
First received: September 27, 2012
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will evaluate the efficacy and safety of different Xelo da (capecitabine) based chemotherapies, alone or in combination with Avastin (be vacizumab), 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 ]

Enrollment: 893
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696695

Locations
Hungary
Budapest, Hungary, 1032
Budapest, Hungary, 1076
Budapest, Hungary, 1088
Budapest, Hungary, 1125
Budapest, Hungary, 1145
Debrecen, Hungary, 4031
Gyor, Hungary, 9024
Gyula, Hungary, 5700
Kecskemet, Hungary, 6000
Kistarcsa, Hungary, 2143
Miskolc, Hungary, 3501
Nyíregyháza, Hungary, 4400
Pecs, Hungary, 7624
Salgótarján, Hungary, 3100
Szeged, Hungary, 6701
Szekesfehervar, Hungary, 8000
Szekszard, Hungary, 7100
Szentes, Hungary, 6600
Szombathely, Hungary, 9700
Tatabanuya, Hungary, 2800
Veszprem, Hungary, 8200
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: August 4, 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 September 22, 2014