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

This study has been completed.
Sponsor:
Information provided by:
Oncozyme Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00810953
First received: December 16, 2008
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Pancreatic Cancer
Drug: Pentamidine
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Clinical Study Using Pentamidine in Patients With Locally Advanced or Metastatic Pancreatic Cancer Undergoing Standard Therapy

Resource links provided by NLM:


Further study details as provided by Oncozyme Pharma Inc.:

Primary Outcome Measures:
  • Any severe events, tumor marker CA19-9, and tumor size (CT scan) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TDP [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: January 2009
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810953

Locations
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Sponsors and Collaborators
Oncozyme Pharma Inc.
Investigators
Principal Investigator: Petr Kavan, MD, Ph.D. McGill University
  More Information

No publications provided

Responsible Party: Dr. Terry Chow/President, Oncozyme Pharma Inc.
ClinicalTrials.gov Identifier: NCT00810953     History of Changes
Other Study ID Numbers: OP-103-P
Study First Received: December 16, 2008
Last Updated: June 27, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Pentamidine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Trypanocidal Agents

ClinicalTrials.gov processed this record on August 19, 2014