Back to resultsS-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
bevacizumab
tegafur-gimeracil-oteracil potassium
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage III colon cancer, stage III rectal cancer, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal carcinoma
- Inoperable, locally advanced, or metastatic disease
- KRAS-mutated
- Concurrently receiving treatment containing irinotecan and oxaliplatin regimens for unresectable or recurrent colorectal cancer
- Measurable disease according to RECIST
- No moderate or severe ascites or pleural effusion requiring treatment
- No metastasis to the CNS
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- White blood cell count > 3,500/mm³ but < 12,000/mm³
- Neutrophil count > 1,500/mm³
- Hemoglobin > 9.0 g/dL
- 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 ≥ 50 mL/min
- Urine dipstick for proteinuria < 1+
- INR < 1.5
- Not pregnant or nursing
- Able to take capsules orally
- No active second cancer
- No active infections (e.g., patients with pyrexia of ≥ 38°C)
- No serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, poorly controlled diabetes, or hypertension)
- No electrocardiographic abnormalities with cardiac disorder that would clinically preclude the execution of the study as judged by the investigator
- No serious drug hypersensitivity or a history of drug allergy
- No thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
- No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- No clinically significant traumatic injury within the past 4 weeks
- No severe mental disorder
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Concurrent low-dose aspirin therapy (< 325 mg/day) allowed
- More than 4 weeks since prior major surgical procedure or open biopsy
- No prior therapy radiotherapy
- No prior therapy with S-1
- No prior chemotherapy include irinotecan and oxaliplatin as first- or second-line treatment.
- No concurrent continuous treatment with steroids
- No concurrent treatment with flucytosine
Sites / Locations
- Osaka Medical CollegeRecruiting
Outcomes
Primary Outcome Measures
Disease-control rate
Secondary Outcome Measures
Response rate
Progression-free survival
Overall survival
Safety
Full Information
NCT ID
NCT00974389
First Posted
September 9, 2009
Last Updated
August 9, 2013
Sponsor
Osaka Medical College
1. Study Identification
Unique Protocol Identification Number
NCT00974389
Brief Title
S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery
Official Title
Phase II Study of Combination Chemotherapy With S-1 Plus Avastin in Unresectable or Recurrent Colorectal Cancer After Failure of Prior Chemotherapy, Including Irinotecan and Oxaliplatin Regimens.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Osaka Medical College
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving S-1 together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving S-1 together with bevacizumab works as third-line therapy in treating patients with colorectal cancer that is recurrent or that cannot be removed by surgery.
Detailed Description
OBJECTIVES:
To evaluate giving S-1 with bevacizumab to see how well it works as third-line therapy in KRAS-mutation patients with unresectable or recurrent colorectal cancer.
OUTLINE: Patients receive oral S-1 twice daily on days 1-28 and bevacizumab IV on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
stage III colon cancer, stage III rectal cancer, stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
tegafur-gimeracil-oteracil potassium
Primary Outcome Measure Information:
Title
Disease-control rate
Secondary Outcome Measure Information:
Title
Response rate
Title
Progression-free survival
Title
Overall survival
Title
Safety
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed colorectal carcinoma
Inoperable, locally advanced, or metastatic disease
KRAS-mutated
Concurrently receiving treatment containing irinotecan and oxaliplatin regimens for unresectable or recurrent colorectal cancer
Measurable disease according to RECIST
No moderate or severe ascites or pleural effusion requiring treatment
No metastasis to the CNS
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
White blood cell count > 3,500/mm³ but < 12,000/mm³
Neutrophil count > 1,500/mm³
Hemoglobin > 9.0 g/dL
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 ≥ 50 mL/min
Urine dipstick for proteinuria < 1+
INR < 1.5
Not pregnant or nursing
Able to take capsules orally
No active second cancer
No active infections (e.g., patients with pyrexia of ≥ 38°C)
No serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, poorly controlled diabetes, or hypertension)
No electrocardiographic abnormalities with cardiac disorder that would clinically preclude the execution of the study as judged by the investigator
No serious drug hypersensitivity or a history of drug allergy
No thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism
No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
No clinically significant traumatic injury within the past 4 weeks
No severe mental disorder
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Concurrent low-dose aspirin therapy (< 325 mg/day) allowed
More than 4 weeks since prior major surgical procedure or open biopsy
No prior therapy radiotherapy
No prior therapy with S-1
No prior chemotherapy include irinotecan and oxaliplatin as first- or second-line treatment.
No concurrent continuous treatment with steroids
No concurrent treatment with flucytosine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hiroya Takiuchi, MD, PhD
Organizational Affiliation
Osaka Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Osaka Medical College
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hiroya Takiuchi, MD, PhD
Phone
81-72-683-1221
12. IPD Sharing Statement
Learn more about this trial
S-1 and Bevacizumab in Treating Patients With Colorectal Cancer That is Recurrent or Cannot Be Removed by Surgery
We'll reach out to this number within 24 hrs