Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
gemcitabine hydrochloride
adjuvant therapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage III pancreatic cancer, stage I pancreatic cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Completely resected disease
Underwent 1 of the following procedures 3-8 weeks ago:
- Standard pancreaticoduodenectomy (for tumors of the pancreatic head)
- Distal pancreatectomy (for tumors of the pancreatic tail)
No grossly positive surgical margins
- Positive microscopic margins allowed
- Nonmeasurable disease
- No known CNS disease
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- CA 19-9 ≤ 2.5 times upper limit of normal (ULN)
- Absolute neutrophil count ≥ 1,500/mm³
- Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
- Platelet count ≥ 100,000/mm³
- INR ≤ 1.5 (except in patients receiving full-dose warfarin)
- Bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times ULN
- Creatinine ≤ 2.0 mg/dL
- No clinically significant impairment of renal function
No postoperative complications, including any of the following:
- Wound dehiscence or infection
- Intra-abdominal abscess
- Pancreatic or biliary leak or fistula
- Grade 3 or 4 delayed hemorrhage (occurring > 5 days postoperatively)
- Bowel perforation
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess within the past 6 months
- No history of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates use of the study drugs or renders the patient at high risk of treatment-related complications
- No other cancer within the past 5 years except basal cell or squamous cell skin cancer
No history of serious systemic disease, including any of the following:
- Myocardial infarction or unstable angina within the past 12 months
- New York Heart Association class II-IV congestive heart failure
Unstable symptomatic arrhythmia requiring medication
- Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
- No history of stroke or transient ischemic attack
- No symptomatic peripheral vascular disease
- No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
- No inadequately controlled hypertension (i.e., blood pressure > 150/100 mm Hg on antihypertensive medication)
- No prior hypertensive crisis or hypertensive encephalopathy
- No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 OR proteinuria ≥ 2+ by dipstick urinalysis OR protein > 1 g by 24-hour urine collection)
- No serious, nonhealing wound or ulcer
- No evidence of bleeding diathesis or coagulopathy
- No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy or radiotherapy for pancreatic cancer
- No prior systemic or investigational therapy for pancreatic cancer
- No major surgical procedure (except for resection of pancreatic cancer) or open biopsy within the past 28 days
- No fine-needle aspiration or core biopsy within the past 7 days
- No anticipated need for a major surgical procedure during study treatment
No concurrent newly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs)
- Concurrent chronic-dose NSAIDs for analgesia are allowed
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
Outcomes
Primary Outcome Measures
Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0
Disease-free survival rate at 1 year
Secondary Outcome Measures
Overall survival rate at 1 and 2 years
Median disease-free survival rate at 1 and 2 years
Median overall survival rate at 1 and 2 years
Full Information
NCT ID
NCT00410774
First Posted
December 11, 2006
Last Updated
September 13, 2012
Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00410774
Brief Title
Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery
Official Title
A Phase I/II Study of Fixed-Dose Rate Gemcitabine and Bevacizumab for Postoperative Adjuvant Treatment of Patients With Resected Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual-no data available
Study Start Date
July 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, 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. Bevacizumab may also stop the growth of pancreatic cancer by blocking blood flow to the tumor. Giving gemcitabine and bevacizumab after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I/II trial is studying the side effects of gemcitabine and bevacizumab and to see how well they work in treating patients with pancreatic cancer that has been completely removed by surgery.
Detailed Description
OBJECTIVES:
Primary
Determine the safety of adjuvant, fixed-dose rate gemcitabine hydrochloride and bevacizumab in patients with completely resected pancreatic cancer.
Determine the 1-year disease-free survival rate in patients treated with this regimen.
Secondary
Determine the 1- and 2-year overall survival rates in these patients.
Determine the median disease-free survival rate in these patients.
Determine the median overall survival rate in these patients.
OUTLINE: This is an open-label, non-randomized study.
Patients receive gemcitabine hydrochloride IV over 100 minutes followed by bevacizumab* IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease recurrence or unacceptable toxicity.
NOTE: *The first dose of bevacizumab is not administered until after 6 weeks have passed since surgery.
After completion of study therapy, patients are followed periodically for 18 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage III pancreatic cancer, stage I pancreatic cancer, adenocarcinoma of the pancreas, stage II pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Primary Outcome Measure Information:
Title
Safety of gemcitabine when administered with bevacizumab as assessed by NCI CTCAE v3.0
Title
Disease-free survival rate at 1 year
Secondary Outcome Measure Information:
Title
Overall survival rate at 1 and 2 years
Title
Median disease-free survival rate at 1 and 2 years
Title
Median overall survival rate at 1 and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
Completely resected disease
Underwent 1 of the following procedures 3-8 weeks ago:
Standard pancreaticoduodenectomy (for tumors of the pancreatic head)
Distal pancreatectomy (for tumors of the pancreatic tail)
No grossly positive surgical margins
Positive microscopic margins allowed
Nonmeasurable disease
No known CNS disease
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after completion of study therapy
CA 19-9 ≤ 2.5 times upper limit of normal (ULN)
Absolute neutrophil count ≥ 1,500/mm³
Hemoglobin ≥ 9 g/dL (transfusion or epoetin alfa allowed)
Platelet count ≥ 100,000/mm³
INR ≤ 1.5 (except in patients receiving full-dose warfarin)
Bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 2.5 times ULN
Creatinine ≤ 2.0 mg/dL
No clinically significant impairment of renal function
No postoperative complications, including any of the following:
Wound dehiscence or infection
Intra-abdominal abscess
Pancreatic or biliary leak or fistula
Grade 3 or 4 delayed hemorrhage (occurring > 5 days postoperatively)
Bowel perforation
No abdominal fistula, gastrointestinal perforation, or intra-abdominal abcess within the past 6 months
No history of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates use of the study drugs or renders the patient at high risk of treatment-related complications
No other cancer within the past 5 years except basal cell or squamous cell skin cancer
No history of serious systemic disease, including any of the following:
Myocardial infarction or unstable angina within the past 12 months
New York Heart Association class II-IV congestive heart failure
Unstable symptomatic arrhythmia requiring medication
Chronic atrial arrhythmia (i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) allowed
No history of stroke or transient ischemic attack
No symptomatic peripheral vascular disease
No significant vascular disease (e.g., aortic aneurysm, aortic dissection)
No inadequately controlled hypertension (i.e., blood pressure > 150/100 mm Hg on antihypertensive medication)
No prior hypertensive crisis or hypertensive encephalopathy
No proteinuria (defined as urine protein:creatinine ratio ≥ 1.0 OR proteinuria ≥ 2+ by dipstick urinalysis OR protein > 1 g by 24-hour urine collection)
No serious, nonhealing wound or ulcer
No evidence of bleeding diathesis or coagulopathy
No significant traumatic injury within the past 28 days
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy or radiotherapy for pancreatic cancer
No prior systemic or investigational therapy for pancreatic cancer
No major surgical procedure (except for resection of pancreatic cancer) or open biopsy within the past 28 days
No fine-needle aspiration or core biopsy within the past 7 days
No anticipated need for a major surgical procedure during study treatment
No concurrent newly prescribed nonsteroidal anti-inflammatory drugs (NSAIDs)
Concurrent chronic-dose NSAIDs for analgesia are allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Ko, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Study Chair
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Gemcitabine and Bevacizumab in Treating Patients With Pancreatic Cancer That Has Been Completely Removed By Surgery
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