Clareo Health | Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Taiho Pharmaceutical Co., Ltd.
Age
65–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
2. Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
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.
You may not be if
1. Serious drug hypersensitivity or a history of drug allergy
2. Active double cancer
3. Active infections (e.g., patients with pyrexia of 38℃ or higher)
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.
