Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
S-1, Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring S-1, Bevacizumab
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
- Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
- 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.
- Treatment with FOLFIRI and FOLFOX is not indicated.
- Age >65 years
- Life expectancy of at least 3 months
- ECOG PS of 0, 1, or 2
Adequate function of major organs as defined below:
- Hemoglobin >9.0 g/dL
- White blood cell count >3,500/mm3, <12,000/mm3
- Neutrophil count >1,500/mm3
- Platelet count >100,000/mm3
- Total bilirubin <1.5 mg/dL
- AST and ALT <100 U/L (<200 U/L in patients with liver metastasis)
- Serum creatinine <1.2 mg/dL
- Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min
- Able to take capsules orally.
- No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
- Voluntary written informed consent.
Exclusion Criteria:
- Serious drug hypersensitivity or a history of drug allergy
- Active double cancer
- Active infections (e.g., patients with pyrexia of 38℃ or higher)
- Uncontrolled hypertension
- Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
- Moderate or severe ascites or pleural effusion requiring treatment
- Watery diarrhea
- Treatment with flucytosine
- Metastasis to the CNS
- Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
- Severe mental disorder
- Continuous treatment with steroids
- Urine dipstick for proteinuria should be <2+
- Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
- Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
- Long-term daily treatment with aspirin (>325 mg/day)
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- Judged ineligible for participation in the study by the investigator for safety reasons.
Sites / Locations
- Osaka Medical College Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
S-1, Bevacizumab
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation
Full Information
NCT ID
NCT00569699
First Posted
December 5, 2007
Last Updated
November 1, 2012
Sponsor
Taiho Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00569699
Brief Title
Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
Official Title
Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taiho Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
S-1, Bevacizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
S-1, Bevacizumab
Intervention Type
Drug
Intervention Name(s)
S-1, Bevacizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
every course for first three courses, then every other course
Secondary Outcome Measure Information:
Title
Safety, Response rate, Time to progression, Time to treatment failure, Overall survival, Treatment situation
Time Frame
any time
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed colorectal carcinoma with inoperable, locally advanced, or metastatic disease, not amenable to curative therapy
Measurable disease or non-measurable but assessable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST)
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.
Treatment with FOLFIRI and FOLFOX is not indicated.
Age >65 years
Life expectancy of at least 3 months
ECOG PS of 0, 1, or 2
Adequate function of major organs as defined below:
Hemoglobin >9.0 g/dL
White blood cell count >3,500/mm3, <12,000/mm3
Neutrophil count >1,500/mm3
Platelet count >100,000/mm3
Total bilirubin <1.5 mg/dL
AST and ALT <100 U/L (<200 U/L in patients with liver metastasis)
Serum creatinine <1.2 mg/dL
Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min
Able to take capsules orally.
No electrocardiographic abnormalities within 28 days before enrollment that would clinically preclude the execution of the study, as judged by the investigator.
Voluntary written informed consent.
Exclusion Criteria:
Serious drug hypersensitivity or a history of drug allergy
Active double cancer
Active infections (e.g., patients with pyrexia of 38℃ or higher)
Uncontrolled hypertension
Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes)
Moderate or severe ascites or pleural effusion requiring treatment
Watery diarrhea
Treatment with flucytosine
Metastasis to the CNS
Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children.
Severe mental disorder
Continuous treatment with steroids
Urine dipstick for proteinuria should be <2+
Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks
Long-term daily treatment with aspirin (>325 mg/day)
History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
Judged ineligible for participation in the study by the investigator for safety reasons.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroya Takiuchi
Organizational Affiliation
Osaka Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka Medical College Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Phase II Trial of Combination Therapy With Bevacizumab and S-1 in Elderly Patients With Unresectable or Recurrent Colorectal Cancer (BASIC)
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