Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer

This study has been completed.
Sponsor:
Collaborator:
Yakult Honsha Co., LTD
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00345761
First received: June 27, 2006
Last updated: August 13, 2010
Last verified: August 2010
  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:


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
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: 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 July 20, 2014