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

Metastatic Colorectal Cancer Clinical Trial

Official title:

A Phase II Study of Combination Chemotherapy With Bevacizumab, Capecitabine and Oxaliplatin in Patients With Previously Untreated Metastatic or Recurrent Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378066
• Other study ID #: AMC-ONCGI-0277
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2006
• Last updated: January 21, 2013
• Start date: August 2006
• Est. completion date: October 2008

Study information

• Verified date: January 2013
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 2008
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Intervention

Drug:
• Bevacizumab
Bevacizumab, Capecitabine, Oxaliplatin

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to progression		6 months	No
Secondary	overall survival, safety, response		1 year	Yes