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

NCT ID: NCT00569335

Last Updated: 2012-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2010-03-31

Brief Summary

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

Conditions

Colorectal, Cancer

Keywords

S-1, Bevacizumab, Irinotecan

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

S-1, Irinotecan, Bevacizumab

Group Type: EXPERIMENTAL

S-1, Irinotecan, Bevacizumab

Intervention Type: DRUG

S-1 is administered orally on days 1 to 14 of a 21-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 <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).

Irinotecan 150 mg/m2 is administered by intravenous infusion on day 1. Bevacizumab 7.5 mg/kg (body weight) is administered by intravenous infusion on day 1.

Interventions

S-1, Irinotecan, Bevacizumab

S-1 is administered orally on days 1 to 14 of a 21-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 <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).

Irinotecan 150 mg/m2 is administered by intravenous infusion on day 1. Bevacizumab 7.5 mg/kg (body weight) is administered by intravenous infusion on day 1.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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)

3. 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

4. Age >20 years

5. Life expectancy of at least 3 months

6. ECOG PS of 0 or 1

7. Adequate function of major organs as defined below:

1. Hemoglobin >9.0 g/dL

2. White blood cell count >3,000/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 (reduce initial dosage by one step if ≥50 but <80 mL/min)

8. Able to take capsules orally.

9. No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.

10. Voluntary written informed consent.

Exclusion Criteria

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)

4. History of gastrointestinal perforation, intestinal tract paralysis, or ileus within 1 year.

5. Uncontrolled hypertension

6. Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)

7. Moderate or severe ascites or pleural effusion requiring treatment

8. Watery diarrhea

9. Treatment with flucytosine or atazanavir sulfate

10. Metastasis to the CNS

11. Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.

12. Severe mental disorder

13. Continuous treatment with steroids

14. Urine dipstick for proteinuria should be <2+

15. Patient with a past history of thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism

16. Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks

17. Long-term daily treatment with aspirin (>325 mg/day)

18. History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding

19. Judged ineligible for participation in the study by the investigator for safety reasons.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yasuhide Yamada

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center Hospital

Locations

National Cancer Center Hospital

Tsukiji, Chuo-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

01023020

Identifier Type: -

Identifier Source: org_study_id