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Sponsored by: |
Taiho Pharmaceutical Co., Ltd. |
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Information provided by: | Taiho Pharmaceutical Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00569699 |
The purpose of this study is to determine whether S-1 and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer |
Drug: S-1, Bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment |
Official Title: | Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC) |
Estimated Enrollment: | 55 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
S-1, Bevacizumab
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Drug: S-1, Bevacizumab
S-1 is administered orally on days 1 to 28 of a 42-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25 m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2). Bevacizumab 5 mg/kg (body weight) is administered by intravenous infusion on days 1, and 15. |
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate function of major organs as defined below:
Exclusion Criteria:
Contact: Hiroya Takiuchi | +81-72-683-1221 | in2028@poh.osaka-med.ac.jp |
Japan, Osaka | |
Osaka Medical College Hospital | Recruiting |
Takatsuki, Osaka, Japan, 569-8686 | |
Contact: Hiroya Takiuchi +81-72-683-1221 in2028@poh.osaka-med.ac.jp |
Principal Investigator: | Hiroya Takiuchi | Osaka Medical College Hospital |
Responsible Party: | Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. ) |
Study ID Numbers: | 01023019 |
Study First Received: | December 5, 2007 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00569699 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
S-1 Bevacizumab |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Gastrointestinal Neoplasms Bevacizumab |
Intestinal Diseases Rectal Diseases Intestinal Neoplasms Recurrence Colorectal Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |