Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer - Full Text View

Purpose

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	Intervention	Phase
Colorectal Cancer	Drug: Bevacizumab Drug: Oxaliplatin Drug: Capecitabine	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Oxaliplatin Capecitabine Bevacizumab

U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:

Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: event driven ] [ Designated as safety issue: No ]
Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

time to progression [ Time Frame: event driven ] [ Designated as safety issue: No ]
overall survival [ Time Frame: event driven ] [ Designated as safety issue: No ]
time to response [ Time Frame: event driven ] [ Designated as safety issue: No ]
duration of response [ Time Frame: event driven ] [ Designated as safety issue: No ]
concentrations of R340 and its metabolites [ Time Frame: throughout study ] [ Designated as safety issue: No ]
concentrations of platinum [ Time Frame: throughout study ] [ Designated as safety issue: No ]
concentrations of bevacizumab [ Time Frame: throughout study ] [ Designated as safety issue: No ]
concentrations of vascular endothelial growth factor (VEGF) [ Time Frame: throughout study ] [ Designated as safety issue: No ]
concentrations of anti-bevacizumab antibody [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment:	64
Study Start Date:	February 2006
Study Completion Date:	July 2010
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

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.

Eligibility

Ages Eligible for Study:	20 Years to 74 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00345761

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

No publications provided

Responsible Party:	Chugai Pharmaceutical CO.,LTD
ClinicalTrials.gov Identifier:	NCT00345761 History of Changes
Other Study ID Numbers:	JO19380
Study First Received:	June 27, 2006
Last Updated:	August 13, 2010
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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
Oxaliplatin
Capecitabine
Bevacizumab

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

ClinicalTrials.gov processed this record on June 18, 2013