A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Pentamidine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically proven diagnosis of advanced pancreatic adenocarcinoma that is unresectable or metastatic. At least one uni-dimensionally measurable lesion (on spiral CT scan)
- 18 years of age or older
- ECOG performance status 0, 1 or 2
- Serum aspartate transaminase (AST) serum alanine transaminase (ALT) £ 2.5 x upper limit of normal (ULN), or AST and ALT £ 5 x ULN if liver function abnormalities are due to underlying malignancy
- Total serum bilirubin £ 2 x ULN
- lipase within normal limits (1.5x ULN)
- Absolute neutrophil count (ANC) ≥ 1500/uL (1.5 x 109/L)
- Platelets ≥ 100,000/uL
- Hemoglobin ≥ 9.0 g/dL
- Serum creatinine £ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min
- CA19-9 level ≥ 37 U/ml
- Normal ECG
- Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment
- Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures
- Life expectancy, in the opinion of the investigator, > 3 months
Exclusion Criteria:
- BP < 100 (systolic)
- History of uncontrolled renal disease, pancreatitis, or diabetes mellitus
- Peripheral sensory neuropathy (> Grade 1, as per NCI CTCAE version 3.0)
- Concomitant therapy with other investigational agents or participation in another clinical trial within the previous 3 months.
- Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval >450 msec for males or >470 msec for females or uncontrolled intercurrent illness, e.g., unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia <50 bpm
- Active uncontrolled bacterial infection
- Concurrent use of drugs that could prolong QT interval
- Concurrent use of nephrotoxic drugs, including aminoglycosides, ampho B, foscarnet, cidofovir
- Concurrent use of drugs that may be associated with pancreatitis
- Concurrent active cancer originating from a primary site other than pancreas or history of cancer < 3 years except for skin superficial bladder, uterus etc
- History of allergy or hypersensitivity to pentamidine
- Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first dose of study medication.
- Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
- On oral anticoagulants (LMWH is acceptable)
Sites / Locations
- McGill University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Use of pentamidine in locally advanced or metastatic pancreatic cancer
Outcomes
Primary Outcome Measures
Any severe events, tumor marker CA19-9, and tumor size (CT scan)
Secondary Outcome Measures
TDP
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00810953
Brief Title
A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy
Official Title
A Phase I/II Clinical Study Using Pentamidine in Patients With Locally Advanced or Metastatic Pancreatic Cancer Undergoing Standard Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oncozyme Pharma Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to investigate the safety and possible efficacy of the use of pentamidine in the treatment of pancreatic cancer metastasis in subjects receiving standard therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
Use of pentamidine in locally advanced or metastatic pancreatic cancer
Intervention Type
Drug
Intervention Name(s)
Pentamidine
Intervention Description
two dose of 6 mg/kg with or without standard chemotherapy.
Primary Outcome Measure Information:
Title
Any severe events, tumor marker CA19-9, and tumor size (CT scan)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
TDP
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically proven diagnosis of advanced pancreatic adenocarcinoma that is unresectable or metastatic. At least one uni-dimensionally measurable lesion (on spiral CT scan)
18 years of age or older
ECOG performance status 0, 1 or 2
Serum aspartate transaminase (AST) serum alanine transaminase (ALT) £ 2.5 x upper limit of normal (ULN), or AST and ALT £ 5 x ULN if liver function abnormalities are due to underlying malignancy
Total serum bilirubin £ 2 x ULN
lipase within normal limits (1.5x ULN)
Absolute neutrophil count (ANC) ≥ 1500/uL (1.5 x 109/L)
Platelets ≥ 100,000/uL
Hemoglobin ≥ 9.0 g/dL
Serum creatinine £ 1.5 x ULN or calculated creatinine clearance ≥ 50 ml/min
CA19-9 level ≥ 37 U/ml
Normal ECG
Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrolment
Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures
Life expectancy, in the opinion of the investigator, > 3 months
Exclusion Criteria:
BP < 100 (systolic)
History of uncontrolled renal disease, pancreatitis, or diabetes mellitus
Peripheral sensory neuropathy (> Grade 1, as per NCI CTCAE version 3.0)
Concomitant therapy with other investigational agents or participation in another clinical trial within the previous 3 months.
Any of the following conditions: Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥ 2; atrial fibrillation of any grade; QTc interval >450 msec for males or >470 msec for females or uncontrolled intercurrent illness, e.g., unstable angina; severe coronary disease, ventricular arrhythmias, bradycardia <50 bpm
Active uncontrolled bacterial infection
Concurrent use of drugs that could prolong QT interval
Concurrent use of nephrotoxic drugs, including aminoglycosides, ampho B, foscarnet, cidofovir
Concurrent use of drugs that may be associated with pancreatitis
Concurrent active cancer originating from a primary site other than pancreas or history of cancer < 3 years except for skin superficial bladder, uterus etc
History of allergy or hypersensitivity to pentamidine
Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) prior to first dose of study medication.
Severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgement of the investigator, excess risk associated with trial participation of study drug administration, or which in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
On oral anticoagulants (LMWH is acceptable)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Petr Kavan, MD, Ph.D.
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy
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