Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
NCT ID: NCT00569699
Last Updated: 2012-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2007-10-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
S-1, Bevacizumab
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
3. 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.
4. Treatment with FOLFIRI and FOLFOX is not indicated.
5. Age \>65 years
6. Life expectancy of at least 3 months
7. ECOG PS of 0, 1, or 2
8. Adequate function of major organs as defined below:
1. Hemoglobin \>9.0 g/dL
2. White blood cell count \>3,500/mm3, \<12,000/mm3
3. Neutrophil count \>1,500/mm3
4. Platelet count \>100,000/mm3
5. Total bilirubin \<1.5 mg/dL
6. AST and ALT \<100 U/L (\<200 U/L in patients with liver metastasis)
7. Serum creatinine \<1.2 mg/dL
8. Creatinine clearance estimate by the Cockcroft-Gault method \>50 mL/min
9. Able to take capsules orally.
10. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
11. Voluntary written informed consent.
Exclusion Criteria
2. Active double cancer
3. Active infections (e.g., patients with pyrexia of 38℃ or higher)
4. Uncontrolled hypertension
5. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
6. Moderate or severe ascites or pleural effusion requiring treatment
7. Watery diarrhea
8. Treatment with flucytosine
9. Metastasis to the CNS
10. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
11. Severe mental disorder
12. Continuous treatment with steroids
13. Urine dipstick for proteinuria should be \<2+
14. Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
15. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
16. Long-term daily treatment with aspirin (\>325 mg/day)
17. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
18. Judged ineligible for participation in the study by the investigator for safety reasons.
65 Years
ALL
No
Sponsors
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Taiho Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Hiroya Takiuchi
Role: PRINCIPAL_INVESTIGATOR
Osaka Medical College Hospital
Locations
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Osaka Medical College Hospital
Takatsuki, Osaka, Japan
Countries
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Other Identifiers
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01023019
Identifier Type: -
Identifier Source: org_study_id