Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345761
• Other study ID #: JO19380
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 27, 2006
• Last updated: August 13, 2010
• Start date: February 2006
• Est. completion date: July 2010

Study information

• Verified date: August 2010
• Source: Chugai Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth [po], day 1 pm-day 15 am every 3 weeks [q3w]), oxaliplatin (130 mg/m2 intravenously [iv], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Description:

This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000 mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 2010
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

• Adult patients 20-74 years of age

• Histologically confirmed colorectal cancer

• Metastatic and/or locally advanced colorectal cancer not previously treated with chemotherapy for metastatic disease

• At least one measurable lesion according to RECIST

Exclusion Criteria:

• Evidence of clinically detectable ascites at study treatment start

• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study; fine needle aspiration within 7 days prior to study treatment start.

• Evidence of bleeding diathesis or coagulopathy

• Serious, non-healing wound, ulcer, or bone fracture

• Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration

Study Design

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Bevacizumab
7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks)
• Oxaliplatin
130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks)
• Capecitabine
2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Locations

Country	Name	City	State
Japan	Hokkaido Region	Hokkaido
Japan	Kanto Region	Kanto
Japan	Kinki Region	Kinki
Japan	Tokai Region	Tokai

Sponsors (2)

Lead Sponsor	Collaborator
Chugai Pharmaceutical	Yakult Honsha Co., LTD

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)		event driven	No
Primary	Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)		throughout study	Yes
Secondary	time to progression		event driven	No
Secondary	overall survival		event driven	No
Secondary	time to response		event driven	No
Secondary	duration of response		event driven	No
Secondary	concentrations of R340 and its metabolites		throughout study	No
Secondary	concentrations of platinum		throughout study	No
Secondary	concentrations of bevacizumab		throughout study	No
Secondary	concentrations of vascular endothelial growth factor (VEGF)		throughout study	No
Secondary	concentrations of anti-bevacizumab antibody		throughout study	No