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

Sponsor

Oncozyme Pharma Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00809796

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: pentamidine	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Mar 1, 2008

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

Any severe events, tumor marker CEA, and tumor size (CT scan) [Three Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00809796

Other Study ID Numbers:

OP-103

First Posted:

Dec 17, 2008

Last Update Posted:

Jun 28, 2011

Last Verified:

Jun 1, 2011

Additional relevant MeSH terms:

Colonic Neoplasms

Pentamidine

Study Results

No Results Posted as of Jun 28, 2011