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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tae Won Kim, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT00378066
First received: September 18, 2006
Last updated: January 21, 2013
Last verified: January 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Asan Medical Center:

Primary Outcome Measures:
  • time to progression [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Tae Won Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT00378066     History of Changes
Other Study ID Numbers: AMC-ONCGI-0277
Study First Received: September 18, 2006
Last Updated: January 21, 2013
Health Authority: Korea: Food and Drug Administration

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
Capecitabine
Oxaliplatin
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 29, 2014