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

NCT00809796 | Completed Phase 1 DMC

• 1 other identifier: OP-103
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Any severe events, tumor marker CEA, and tumor size (CT scan)

  Three Months

Study Arms (1)

single arm

EXPERIMENTAL

Use of pentamidine in second and/or third line metastatic colon cancer

Drug: pentamidine

Interventions

pentamidine DRUG

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.

single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oncozyme Pharma Inc.: lead

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Pentamidine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Benzamidines; Amidines; Organic Chemicals

Study Officials

• Petr Kavan, MD, Ph.D.

  Jewish General Hospital/McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 15, 2008
• First Posted: December 17, 2008
• Study Start: March 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 28, 2011

Record last verified: 2011-06

Locations

CA (1)