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

Taiho Pharmaceutical Co., Ltd.1 site in 1 country56 target enrollmentOctober 2007

Overview

The purpose of this study is to determine whether S-1 and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

March 2011

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.
•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

•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.