A Safety Study Using Pentamidine in Patients With Pancreatic Cancer Undergoing Standard Therapy

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Drug: Pentamidine

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1S6
      • McGill University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single arm; Use of pentamidine in locally advanced or metastatic pancreatic cancer	Drug: Pentamidine; two dose of 6 mg/kg with or without standard chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Any severe events, tumor marker CA19-9, and tumor size (CT scan)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
TDP	6 months

Collaborators and Investigators

• Sponsor: Oncozyme Pharma Inc.
• Investigators: Principal Investigator: Petr Kavan, MD, Ph.D., McGill University

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 16, 2008
• First Submitted That Met QC Criteria: December 17, 2008
• First Posted (Estimate): December 18, 2008

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms; Anti-Infective Agents; Antifungal Agents; Antiprotozoal Agents; Antiparasitic Agents; Trypanocidal Agents; Pentamidine
• Other Study ID Numbers: OP-103-P