Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
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ClinicalTrials.gov Identifier: NCT00345761 |
Recruitment Status
:
Completed
First Posted
: June 28, 2006
Last Update Posted
: August 16, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: Bevacizumab Drug: Oxaliplatin Drug: Capecitabine | Phase 1 Phase 2 |
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 |

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)
|
- Response rate: Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: event driven ]
- Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0) [ Time Frame: throughout study ]
- time to progression [ Time Frame: event driven ]
- overall survival [ Time Frame: event driven ]
- time to response [ Time Frame: event driven ]
- duration of response [ Time Frame: event driven ]
- concentrations of R340 and its metabolites [ Time Frame: throughout study ]
- concentrations of platinum [ Time Frame: throughout study ]
- concentrations of bevacizumab [ Time Frame: throughout study ]
- concentrations of vascular endothelial growth factor (VEGF) [ Time Frame: throughout study ]
- concentrations of anti-bevacizumab antibody [ Time Frame: throughout study ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345761
Japan | |
Hokkaido Region | |
Hokkaido, Japan | |
Kanto Region | |
Kanto, Japan | |
Kinki Region | |
Kinki, Japan | |
Tokai Region | |
Tokai, Japan |
Study Chair: | Yuji Hayashi | Clinical Development Department 3, Group 6 |
Responsible Party: | Chugai Pharmaceutical CO.,LTD |
ClinicalTrials.gov Identifier: | NCT00345761 History of Changes |
Other Study ID Numbers: |
JO19380 |
First Posted: | June 28, 2006 Key Record Dates |
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 |