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

Taiho Pharmaceutical Co., Ltd.1 site in 1 country52 target enrollmentOctober 2007

Overview

Phase II trial of combination therapy with S-1, irinotecan, and bevacizumab (SIRB) in patients with unresectable or recurrent colorectal cancer

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

March 2010

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•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.
•Preoperative or postoperative irradiation (\<30 Gy) for rectal cancer is possible
•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 \>9.0 g/dL
•White blood cell count \>3,000/mm3

•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

S-1, Irinotecan, Bevacizumab

Intervention: S-1, Irinotecan, Bevacizumab

Safety

Time Frame: any time

Progression-free survival, Response rate, Overall survival, Time to treatment failure, Treatment situation(every course for first three courses, then every other course)