A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine, Bosutinib
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring pancreas, pancreatic, bosutinib, SKI-606, gemcitabine, gemzar, Patients with resected pancreatic cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically proven adenocarcinoma of the pancreas.
- Complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). Positive microscopic margins are allowable.
- No measurable disease.
- ECOG performance status 0 - 1.
- ≥ 18 years of age.
- Ability to start adjuvant therapy within 8 weeks after pancreatic cancer surgery (but no sooner than 3 weeks).
- CA 19-9 ≤ 2.5 times the upper limit of normal.
- ANC (absolute neutrophil count) ≥ 1500/μL
- Hemoglobin ≥ 9 gm/dL (may be transfused or may receive epoetin alfa to maintain this level)
- Platelet count ≥ 100,000/μL
- INR ≤ 1.5 (except those subjects who are receiving full-dose warfarin)
- Total bilirubin ≤ 2.0 mg/dL
- AST and ALT ≤ 2.5 times the upper limit of normal
- Serum creatinine ≤ 2.0
- Negative pregnancy test for women of childbearing potential (serum or urine beta-HCG).
- All patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
- Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards.
- At least one paraffin block from patient's pancreatic cancer surgery must be available for analysis (does not necessarily need to be received by the start of study treatment).
Exclusion Criteria:
- Any prior systemic or investigational therapy for pancreatic cancer.
- Grossly positive surgical margins.
- Any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula.
- History of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications.
- Serious active ongoing infection, including any requiring parenteral antibiotics.
- Patients with a "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse.
- Pregnancy (positive pregnancy test) or lactation.
- Known central nervous system disease.
- Inability to swallow pills/tolerate oral intake.
- Inability to comply with study and/or follow-up procedures.
Sites / Locations
- UCSF Helen Diller Family Comprehensive Cancer Center
- Huntsman Cancer Institute, University of Utah
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gem/Bos
Arm Description
Gemcitabine 1000 mg/m2, D1,8,15 of each cycle Bostutinib 400 mg daily concurrently with Gemcitabine
Outcomes
Primary Outcome Measures
To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer.
To estimate the median disease-free survival rate of patients with completely resected pancreatic cancer treated with this combination
Secondary Outcome Measures
To determine the overall survival rates of patients with completely resected pancreatic cancer when treated postoperatively with the combination of gemcitabine and bosutinib
To estimate both disease-free and overall survival at one and two years of patients with completely resected pancreatic cancer treated with this combination
Full Information
NCT ID
NCT01025570
First Posted
December 1, 2009
Last Updated
May 7, 2014
Sponsor
University of California, San Francisco
Collaborators
University of Utah
1. Study Identification
Unique Protocol Identification Number
NCT01025570
Brief Title
A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer
Official Title
A Study Evaluating Safety and Efficacy of Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Adenocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to slow accrual
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to find out the effects, good and/or bad, of the combination of two drugs, gemcitabine and bosutinib, in patients with resected pancreatic cancer and whether this combination can prevent pancreatic cancer from coming back.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
pancreas, pancreatic, bosutinib, SKI-606, gemcitabine, gemzar, Patients with resected pancreatic cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gem/Bos
Arm Type
Experimental
Arm Description
Gemcitabine 1000 mg/m2, D1,8,15 of each cycle
Bostutinib 400 mg daily concurrently with Gemcitabine
Intervention Type
Drug
Intervention Name(s)
Gemcitabine, Bosutinib
Intervention Description
Gemcitabine, 1000 mg/m2 on D1,8,15 over 30 mins standard infusion rate Bosutinib 400 mg, oral, once daily
Primary Outcome Measure Information:
Title
To evaluate the safety of using the combination of gemcitabine and bosutinib in the postoperative adjuvant treatment of patients with completely resected pancreatic cancer.
Time Frame
8 weeks after the 6th patient is enrolled
Title
To estimate the median disease-free survival rate of patients with completely resected pancreatic cancer treated with this combination
Time Frame
2 years after last patient is enrolled
Secondary Outcome Measure Information:
Title
To determine the overall survival rates of patients with completely resected pancreatic cancer when treated postoperatively with the combination of gemcitabine and bosutinib
Time Frame
2 years after last patient is enrolled
Title
To estimate both disease-free and overall survival at one and two years of patients with completely resected pancreatic cancer treated with this combination
Time Frame
2 years after last patient is enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically proven adenocarcinoma of the pancreas.
Complete resection by standard pancreaticoduodenectomy (for tumors of the pancreatic head) or distal pancreatectomy (for tumors of the pancreatic tail). Positive microscopic margins are allowable.
No measurable disease.
ECOG performance status 0 - 1.
≥ 18 years of age.
Ability to start adjuvant therapy within 8 weeks after pancreatic cancer surgery (but no sooner than 3 weeks).
CA 19-9 ≤ 2.5 times the upper limit of normal.
ANC (absolute neutrophil count) ≥ 1500/μL
Hemoglobin ≥ 9 gm/dL (may be transfused or may receive epoetin alfa to maintain this level)
Platelet count ≥ 100,000/μL
INR ≤ 1.5 (except those subjects who are receiving full-dose warfarin)
Total bilirubin ≤ 2.0 mg/dL
AST and ALT ≤ 2.5 times the upper limit of normal
Serum creatinine ≤ 2.0
Negative pregnancy test for women of childbearing potential (serum or urine beta-HCG).
All patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
Women or men of reproductive potential must agree to use an effective contraceptive method during treatment and for 6 months afterwards.
At least one paraffin block from patient's pancreatic cancer surgery must be available for analysis (does not necessarily need to be received by the start of study treatment).
Exclusion Criteria:
Any prior systemic or investigational therapy for pancreatic cancer.
Grossly positive surgical margins.
Any of the following post-operative complications: wound dehiscence or infection, intraabdominal abscess, pancreatic or biliary leak or fistula.
History of major psychiatric disorder or other chronic medical illness that, in the opinion of the treating physician, contraindicates the use of the investigational drugs in this protocol or that might render the subject at high risk of treatment related complications.
Serious active ongoing infection, including any requiring parenteral antibiotics.
Patients with a "currently active" second malignancy other than non-melanoma skin cancer. Patients are not considered to have a "currently active" malignancy if they have completed therapy and considered by their physician to be at less than 30% risk of relapse.
Pregnancy (positive pregnancy test) or lactation.
Known central nervous system disease.
Inability to swallow pills/tolerate oral intake.
Inability to comply with study and/or follow-up procedures.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew H. Ko, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Huntsman Cancer Institute, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
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A Study Evaluating Gemcitabine Plus Bosutinib for Patients With Resected Pancreatic Cancer
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