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Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
This study is currently recruiting participants.
Verified by Taiho Pharmaceutical Co., Ltd., July 2008
Sponsored by: Taiho Pharmaceutical Co., Ltd.
Information provided by: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00569699
  Purpose

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


Condition Intervention Phase
Colorectal Cancer
Drug: S-1, Bevacizumab
Phase II

MedlinePlus related topics: Cancer Colorectal Cancer
Drug Information available for: Bevacizumab S 1 (Combination)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title: Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)

Further study details as provided by Taiho Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation [ Time Frame: any time ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 55
Study Start Date: October 2007
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
S-1, Bevacizumab
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.


  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00569699

Contacts
Contact: Hiroya Takiuchi +81-72-683-1221 in2028@poh.osaka-med.ac.jp

Locations
Japan, Osaka
Osaka Medical College Hospital Recruiting
Takatsuki, Osaka, Japan, 569-8686
Contact: Hiroya Takiuchi     +81-72-683-1221     in2028@poh.osaka-med.ac.jp    
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Hiroya Takiuchi Osaka Medical College Hospital
  More Information

Responsible Party: Taiho Pharmaceutical Co., Ltd. ( Taiho Pharmaceutical Co., Ltd. )
Study ID Numbers: 01023019
Study First Received: December 5, 2007
Last Updated: July 2, 2008
ClinicalTrials.gov Identifier: NCT00569699  
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiho Pharmaceutical Co., Ltd.:
S-1
Bevacizumab

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Bevacizumab
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Recurrence
Colorectal Neoplasms

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009