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Phase II Study of Bevacizumab, Capecitabine and Oxaliplatin in Colon Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00378066
First Posted: September 19, 2006
Last Update Posted: January 23, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center
  Purpose
The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.

Condition Intervention Phase
Metastatic Colorectal Cancer Drug: Bevacizumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Tae Won Kim, Asan Medical Center:

Primary Outcome Measures:
  • time to progression [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • overall survival, safety, response [ Time Frame: 1 year ]

Enrollment: 49
Study Start Date: August 2006
Study Completion Date: October 2008
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bevacizumab
Bevacizumab, capecitabine and oxaliplatin for metastatic colorectal cancer, 1st line treatment
Drug: Bevacizumab
Bevacizumab, Capecitabine, Oxaliplatin
Other Name: Capecitabine, Oxaliplatin

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically documented colorectal adenocarcinoma
  • ECOG performance status of 2 or lower
  • Adequate bone marrow function
  • Adequate kidney function
  • Adequate liver function
  • Informed consent

Exclusion Criteria:

  • Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
  • Known allergy to study drugs
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378066


Locations
Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Yonsei University Hospital
Seoul, Korea, Republic of
Bundang Seoul National University Hospital
Sungnam, Korea, Republic of
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Tae Won Kim, M.D. Asan Medical Center
  More Information

Responsible Party: Tae Won Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00378066     History of Changes
Other Study ID Numbers: AMC-ONCGI-0277
First Submitted: September 18, 2006
First Posted: September 19, 2006
Last Update Posted: January 23, 2013
Last Verified: January 2013

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
Bevacizumab
Oxaliplatin
Capecitabine
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action