A Safety Study of Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Chemotherapy as Second-line and/or Third-line Treatment

This study has been completed.
Sponsor:
Information provided by:
Oncozyme Pharma Inc.
ClinicalTrials.gov Identifier:
NCT00809796
First received: December 15, 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 colon cancer metastasis in subjects receiving standard therapy.


Condition Intervention Phase
Colorectal Cancer
Drug: pentamidine
Phase 1
Phase 2

Study Type: Interventional
Study Design: 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 Metastatic Colon Cancer Undergoing Standard Folinic Acid, 5-Fluorouracil, or Capecitabine and Oxaliplatin Chemotherapy as Second-line and/or Third-line Treatment

Resource links provided by NLM:


Further study details as provided by Oncozyme Pharma Inc.:

Primary Outcome Measures:
  • Any severe events, tumor marker CEA, and tumor size (CT scan) [ Time Frame: Three Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: March 2008
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm
Use of pentamidine in second and/or third line metastatic colon cancer
Drug: pentamidine
one dose of 4 mg/kg to two dose of 4 mg/kg with possibility of escalated to 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 adenocarcinoma of the colon or rectum with evidence of (1) unresectable, locally recurrent, or (2) metastatic disease
  • Failure of first-line or second-line therapy for colorectal cancer
  • At least one unidimensional 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 £ 1.5 x ULN
  • Serum albumin ≥ 3.0 g/dL
  • lipase within normal limits
  • 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
  • Magnesium ≥ lower limit of normal
  • CEA level ≥ 3.4 ng/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 enrollment
  • 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 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
  • 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 colon/rectum, except for surgically treated nonmelanoma skin cancer, in situ cervical cancer, or localized prostate cancer with undetectable PSA level
  • Co-existing lung disease
  • 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
  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: NCT00809796

Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Oncozyme Pharma Inc.
Investigators
Principal Investigator: Petr Kavan, MD, Ph.D. Jewish General Hospital/McGill University
  More Information

No publications provided

Responsible Party: Dr. Terry Chow/President, Oncozyme Pharma Inc.
ClinicalTrials.gov Identifier: NCT00809796     History of Changes
Other Study ID Numbers: OP-103
Study First Received: December 15, 2008
Last Updated: June 27, 2011
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pentamidine
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Trypanocidal Agents

ClinicalTrials.gov processed this record on September 22, 2014