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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Three Months

Safety Issue:

Yes

Principal Investigator

Petr Kavan, MD, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jewish General Hospital/McGill University

Authority:

Canada: Canadian Institutes of Health Research

Study ID:

OP-103

NCT ID:

NCT00809796

Start Date:

March 2008

Completion Date:

June 2011

Related Keywords:

  • Colorectal Cancer
  • Colonic Neoplasms
  • Colorectal Neoplasms

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