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The purpose of this study is to determine whether S-1 and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | S-1, Bevacizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-1, Bevacizumab | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | every course for first three courses, then every other course |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation | any time |
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Inclusion Criteria:
Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Patients with no previous treatment (radiotherapy or chemotherapy). Patients who have received postoperative adjuvant chemotherapy are eligible if relapse is diagnosed more than 180 days after the end of such treatment.
Treatment with FOLFIRI and FOLFOX is not indicated.
Age >65 years
Life expectancy of at least 3 months
ECOG PS of 0, 1, or 2
Adequate function of major organs as defined below:
Able to take capsules orally.
No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
Voluntary written informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hiroya Takiuchi | Osaka Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka Medical College Hospital | Takatsuki | Osaka | 569-8686 | Japan |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| C079198 | S 1 (combination) |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |