Text Size

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

December 5, 2007
November 1, 2012
October 2007
March 2011   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: every course for first three courses, then every other course ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: 2 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00569699 on ClinicalTrials.gov Archive Site
Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation [ Time Frame: any time ] [ Designated as safety issue: Yes ]
Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation [ Time Frame: 2 ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)

The purpose of this study is to determine whether S-1 and bevacizumab are safe in the treatment of unresectable or recurrent colorectal cancer
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
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.
Experimental: 1
S-1, Bevacizumab
Intervention: Drug: S-1, Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00569699
01023019
Yes
Taiho Pharmaceutical Co., Ltd.
Taiho Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Hiroya Takiuchi Osaka Medical College Hospital
Taiho Pharmaceutical Co., Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP