NCT00569790
Completed
Phase 2
Phase II Trial of Combination Therapy With Irinotecan, S-1, and Bevacizumab (IRIS/Bev) in Patients With Unresectable or Recurrent Colorectal Cancer
ConditionsColorectal Cancer
InterventionsS-1, Irinotecan, Bevacizumab
Overview
- Phase
- Phase 2
- Intervention
- S-1, Irinotecan, Bevacizumab
- Conditions
- Colorectal Cancer
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Safety
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to determine whether irinotecan, S-1, and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer
Investigators
Eligibility Criteria
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.
- •Age ≥20 years
- •Life expectancy of at least 3 months
- •ECOG PS of 0 or 1
- •Adequate function of major organs as defined below:
- •Hemoglobin ≥9.0g/dL
- •White blood cell count ≥3,500/mm3
- •Neutrophil count ≥1,500/mm3
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)
- •History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.
- •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 or atazanavir sulfate
- •Metastasis to the CNS
Arms & Interventions
1
S-1, Irinotecan, Bevacizumab
Intervention: S-1, Irinotecan, Bevacizumab
Outcomes
Primary Outcomes
Safety
Time Frame: any time
Secondary Outcomes
- Progression-free survival, Response rate, Overall survival, Treatment situation(every course for first three courses, then every other course)
Study Sites (1)
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