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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00809796
Recruitment Status : Completed
First Posted : December 17, 2008
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Oncozyme Pharma Inc.

Tracking Information
First Submitted Date  ICMJE December 15, 2008
First Posted Date  ICMJE December 17, 2008
Last Update Posted Date June 28, 2011
Study Start Date  ICMJE March 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2008)
Any severe events, tumor marker CEA, and tumor size (CT scan) [ Time Frame: Three Months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00809796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of Pentamidine in Patients With Metastatic Colon Cancer Undergoing Standard Chemotherapy as Second-line and/or Third-line Treatment
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: single arm
Use of pentamidine in second and/or third line metastatic colon cancer
Intervention: Drug: pentamidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 16, 2008)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00809796
Other Study ID Numbers  ICMJE OP-103
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Terry Chow/President, Oncozyme Pharma Inc.
Study Sponsor  ICMJE Oncozyme Pharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Petr Kavan, MD, Ph.D. Jewish General Hospital/McGill University
PRS Account Oncozyme Pharma Inc.
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP