Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)

Study Overview
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Brief Summary
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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

Official Title
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Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: S-1, Bevacizumab


Participation Criteria
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Eligibility Criteria
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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: Hemoglobin >9.0 g/dL White blood cell count >3,500/mm3, <12,000/mm3 Neutrophil count >1,500/mm3 Platelet count >100,000/mm3 Total bilirubin <1.5 mg/dL AST and ALT <100 U/L (<200 U/L in patients with liver metastasis) Serum creatinine <1.2 mg/dL Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min 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: Serious drug hypersensitivity or a history of drug allergy Active double cancer Active infections (e.g., patients with pyrexia of 38℃ or higher) Uncontrolled hypertension Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes) Moderate or severe ascites or pleural effusion requiring treatment Watery diarrhea Treatment with flucytosine Metastasis to the CNS Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. Severe mental disorder Continuous treatment with steroids Urine dipstick for proteinuria should be <2+ Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks Long-term daily treatment with aspirin (>325 mg/day) History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding Judged ineligible for participation in the study by the investigator for safety reasons.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>S-1, Bevacizumab | Drug: S-1, Bevacizumab<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival |  | every course for first three courses, then every other course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation |  | any time | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-1, Bevacizumab