Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer	Drug: Bevacizumab; Drug: Oxaliplatin; Drug: Capecitabine	Phase 1; Phase 2

Detailed 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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	64 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer
Study Start Date :	February 2006
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	July 2010

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Step 1	Drug: Oxaliplatin; 130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks) Drug: Capecitabine; 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
Experimental: Step 2	Drug: Bevacizumab; 7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks) Drug: Oxaliplatin; 130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks) Drug: Capecitabine; 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)
Experimental: Step 3	Drug: Bevacizumab; 7.5 mg/kg(i.v.) on Day 1 of 1 cycle(3 weeks) Drug: Oxaliplatin; 130 mg/m2(i.v.) on Day 1 of 1 cycle(3 weeks) Drug: Capecitabine; 2000 mg/m2/day(p.o.) for 14 days in 1 cycle(3 weeks)

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: event driven ]
2. Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) [ Time Frame: throughout study ]

Secondary Outcome Measures :

1. time to progression [ Time Frame: event driven ]
2. overall survival [ Time Frame: event driven ]
3. time to response [ Time Frame: event driven ]
4. duration of response [ Time Frame: event driven ]
5. concentrations of R340 and its metabolites [ Time Frame: throughout study ]
6. concentrations of platinum [ Time Frame: throughout study ]
7. concentrations of bevacizumab [ Time Frame: throughout study ]
8. concentrations of vascular endothelial growth factor (VEGF) [ Time Frame: throughout study ]
9. concentrations of anti-bevacizumab antibody [ Time Frame: throughout study ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	20 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Japan
Hokkaido Region
Hokkaido, Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Tokai Region
Tokai, Japan

Sponsors and Collaborators

Chugai Pharmaceutical

Yakult Honsha Co., LTD

Investigators

Study Chair:	Yuji Hayashi	Clinical Development Department 3, Group 6

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Chugai Pharmaceutical CO.,LTD
ClinicalTrials.gov Identifier:	NCT00345761 History of Changes
Other Study ID Numbers:	JO19380
First Posted:	June 28, 2006
Last Update Posted:	August 16, 2010
Last Verified:	August 2010

Keywords provided by Chugai Pharmaceutical:

Advanced and/or metastatic colorectal cancer

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