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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569699
• Other study ID #: 01023019
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2007
• Last updated: November 1, 2012
• Start date: October 2007
• Est. completion date: March 2011

Study information

• Verified date: November 2012
• Source: Taiho Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

4. Treatment with FOLFIRI and FOLFOX is not indicated.

5. Age >65 years

6. Life expectancy of at least 3 months

7. ECOG PS of 0, 1, or 2

8. Adequate function of major organs as defined below:

1. Hemoglobin >9.0 g/dL

2. White blood cell count >3,500/mm3, <12,000/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

9. Able to take capsules orally.

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

11. 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. Uncontrolled hypertension

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

6. Moderate or severe ascites or pleural effusion requiring treatment

7. Watery diarrhea

8. Treatment with flucytosine

9. Metastasis to the CNS

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

11. Severe mental disorder

12. Continuous treatment with steroids

13. Urine dipstick for proteinuria should be <2+

14. Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism

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

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

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

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• S-1, Bevacizumab
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.

Locations

Country	Name	City	State
Japan	Osaka Medical College Hospital	Takatsuki	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Taiho Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		every course for first three courses, then every other course	No
Secondary	Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation		any time	Yes