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A Phase I/II Clinical Study Using Pentamidine in Patients With Locally Advanced or Metastatic Pancreatic Cancer Undergoing Standard Therapy

Phase 1/Phase 2
18 Years
Not Enrolling
Pancreatic Cancer

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Trial Information

A Phase I/II Clinical Study Using Pentamidine in Patients With Locally Advanced or Metastatic Pancreatic Cancer Undergoing Standard Therapy

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,

- 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

- 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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Any severe events, tumor marker CA19-9, and tumor size (CT scan)

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Petr Kavan, MD, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University


Canada: Health Canada

Study ID:




Start Date:

January 2009

Completion Date:

June 2011

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms