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Sponsors and Collaborators: |
Chugai Pharmaceutical Yakult Honsha Co., LTD |
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Information provided by: | Chugai Pharmaceutical |
ClinicalTrials.gov Identifier: | NCT00345761 |
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 |
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Colorectal Cancer |
Drug: Bevacizumab Drug: Oxaliplatin Drug: Capecitabine |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer |
Enrollment: | 64 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | July 2009 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Step 1: Experimental |
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)
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Step 2: Experimental |
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)
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Step 3: Experimental |
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)
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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.
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 ( Chugai Pharmaceutical CO.,LTD ) |
Study ID Numbers: | JO19380 |
Study First Received: | June 27, 2006 |
Last Updated: | July 28, 2009 |
ClinicalTrials.gov Identifier: | NCT00345761 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Advanced and/or metastatic colorectal cancer |
Antimetabolites Capecitabine Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Bevacizumab Intestinal Diseases |
Angiogenesis Inhibitors Rectal Diseases Intestinal Neoplasms Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Colonic Diseases Physiological Effects of Drugs Bevacizumab Rectal Diseases Oxaliplatin Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents |
Growth Inhibitors Capecitabine Digestive System Neoplasms Growth Substances Intestinal Diseases Angiogenesis Inhibitors Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms |