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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00569699
First received: December 5, 2007
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

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 ]

Enrollment: 56
Study Start Date: October 2007
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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

Locations
Japan
Osaka Medical College Hospital
Takatsuki, Osaka, Japan, 569-8686
Sponsors and Collaborators
Taiho Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Hiroya Takiuchi Osaka Medical College Hospital
  More Information

No publications provided

Responsible Party: Taiho Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00569699     History of Changes
Other Study ID Numbers: 01023019
Study First Received: December 5, 2007
Last Updated: November 1, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013