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Using OCZ103-OS in Patients With Unresectable and Locally Recurrent or Metastatic Colorectal Cancer Undergoing Standard Chemotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oncozyme Pharma Inc.
ClinicalTrials.gov Identifier:
NCT01378143
First received: June 15, 2011
Last updated: October 20, 2014
Last verified: February 2013
  Purpose

The purpose of this study is to investigate the safety and efficacy of the use of OCZ103-OS in combination with standard of care as a second line treatment in subjects with unresectable and locally recurrent or metastatic colorectal cancer.


Condition Intervention Phase
Colorectal Cancer
Drug: OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI
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 II Clinical Study Using OCZ103-OS in Patients With Unresectable and Locally Recurrent or Metastatic Colorectal Cancer Undergoing Standard Chemotherapy (mFOLFOX6 or FOLFIRI) as Second-Line Treatment

Resource links provided by NLM:


Further study details as provided by Oncozyme Pharma Inc.:

Primary Outcome Measures:
  • Tumor size (CT scan) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the antitumor activity of OCZ103-OS in combination with standard of care in subjects with unresectable and locally recurrent or metastatic colorectal cancer in terms of tumor growth during treatment

  • Progression free survival (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the antitumor activity of OCZ103-OS in combination with standard of care in subjects with unresectable and locally recurrent or metastatic colorectal cancer in terms of progression free survival

  • Overall survival (OS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    To assess the antitumor activity of OCZ103-OS in combination with standard of care in subjects with unresectable and locally recurrent or metastatic colorectal cancer in terms of overall survival


Secondary Outcome Measures:
  • Peak plasma concentration (Cmax) of OCZ103-OS [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    • To assess the peak plasma concentration of OCZ103-OS after administration on day 1 of first cycle.
    • Amount of OCZ103-OS in serum on day 1 of first cycle.

  • Number of participants with Adverse Events (AE) as a Measure of Safety and Tolerability [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    - To assess the number of adverse events in participants due to IV OCZ103-OS in conjunction with standard chemotherapy (mFOLFOX6- or FOLFIRI-contained regimen) in patients with unresectable and locally recurrent or metastatic colorectal cancer requiring second-line chemotherapy from baseline.

  • Objective response (OR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    - To assess the effect of OCZ103-OS on overall objective response (OR) in subjects with unresectable and locally recurrent or metastatic colorectal cancer treated concurrently with mFOLFOX6 or FOLFIRI.

  • Duration of response (DR) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    - To assess the effect of OCZ103-OS on duration of response (DR) in subjects with unresectable and locally recurrent or metastatic colorectal cancer treated concurrently with mFOLFOX6 or FOLFIRI.


Enrollment: 53
Study Start Date: March 2011
Study Completion Date: July 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OCZ103-OS, mFOLFOX6 or FOLFIRI
OCZ103-OS in combination with mFOLFOX6 or FOLFIRI as standard of care
Drug: OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI
OCZ103-OS is given in combination with Chemotherapy each cycle

Detailed Description:

This is a single arm, open label study to investigate the safety and efficacy of the use of OCZ103-OS in combination with standard therapy (mFOLFOX6 or FOLFIRI) as a second line treatment in subjects with unresectable and locally recurrent or metastatic colorectal cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically or cytologically proven diagnosis of adenocarcinoma of the colon/rectum with evidence of (1) unresectable and, locally recurrent, or (2) metastatic disease.
  2. Failure of first-line therapy(5-Fu-based therapy +/- bevacizumab) for metastatic colorectal cancer.
  3. At least one (1) unidimensionally measurable lesion (on spiral CT scan).
  4. 18 years of age or older.
  5. ECOG performance status 0, 1 or 2.
  6. Serum aspartate transaminase (AST), serum alanine transaminase (ALT), serum alkaline phosphatase (ALP) ≤ 2.5 x upper limit of normal (ULN), or AST,ALT, ALP ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy
  7. Total serum bilirubin ≤ 1.5 x ULN
  8. Lipase and amylase within normal limits or abnormal limits but deemed not clinically significant.
  9. Absolute neutrophil count (ANC) ≥ 1500/µL (1.5 x 10e9/L)
  10. Platelets ≥ 100,000/µL (100 x 10e9/L)
  11. Hemoglobin ≥ 90 g/L
  12. Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance ≥ 60 ml/min. The Cockcroft-Gault formula to be used is as follows:

    eCcr=(140-age)x Mass(in kilogram)x Constant/Serum Creatinine(in µmol/L)

    Where Constant is 1.23 for men and 1.04 for women.

  13. Normal or abnormal ECG. If ECG shows abnormalities, they must be deemed not clinically significant.
  14. Signed and dated Informed Consent Form indicating that the subject (or legally acceptable representative) has been informed of all the pertinent aspects of the trial prior to enrollment.
  15. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  16. Life expectancy, in the opinion of the investigator, > 3 months.

Exclusion criteria

  1. Systolic Blood Pressure <100 mmHg (if deemed clinically significant by the treating physician).
  2. Uncontrolled diabetes, severe renal impairment or pancreatitis.
  3. Concomitant therapy with other investigational agents or participation in another clinical trial within 30 days prior to enrollment.
  4. 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; a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia or family history of Long QT Syndrome).
  5. Active uncontrolled bacterial infection.
  6. Concurrent use of drugs that could prolong QT interval (NB: pentamidine is known to induce torsades de pointes) (see Appendix II: List of drugs that could prolong QT interval / we also suggest that you refer to the following link: http://www.azcert.org/medical-pros/drug-lists/bycategory.cfm).
  7. Concurrent use of nephrotoxic drugs (depending on the medical health status of the patient and based on the judgment of the investigator), including but not limited to aminoglycosides, ampho B, foscarnet and cidofovir.
  8. Concurrent use of drugs such as Rifampine and Lamivudine, since these that may be associated with pancreatitis.
  9. Prior malignancy other than colorectal cancer (except for adequately treated carcinoma in situ of the cervix, non-melanoma skin cancer or localized prostate cancer with undetectable PSA level) unless the prior malignancy was diagnosed and definitively treated at least five (5) years previously with no subsequent evidence of recurrence.
  10. Clinically significant non-malignant lung disease.
  11. History of allergy or hypersensitivity to pentamidine.
  12. 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.
  13. 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.
  14. Use of oral anticoagulants (LMWH is acceptable)
  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: NCT01378143

Locations
Canada, Quebec
CSSS Champlain - Charles-Lemoyne Hospital
Greenfield Park, Quebec, Canada, J4V 2H1
CSSS Alphonse-Desjardins (CHAU Hotel-Dieu de Levis)
Levis, Quebec, Canada
CHUM-St. Luc Hospital
Montreal, Quebec, Canada, H2X 3J4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
CHUS-Centre de recherche Etienne-Le Bel
Sherbrooke, Quebec, Canada, J1H 5N4
CSSS St-Jérome
St-Jérome, Quebec, Canada
Canada
Hotel-Dieu de Quebec
Quebec, Canada, G1R 2J6
Sponsors and Collaborators
Oncozyme Pharma Inc.
Investigators
Principal Investigator: Petr Kavan, MD, Ph.D. Jewish General Hospital
Principal Investigator: Benoit Samson, MD CSSS Champlain - Charles-Lemoyne Hospital
Principal Investigator: Richard Letourneau, MD St. Luc Hospital
Principal Investigator: Felix Couture, MD Hotel-Dieu de Quebec
Principal Investigator: Felix Couture, MD CSSS Alphonse-Desjardins
Principal Investigator: Annie Beaudoin, M.D. CHUS-Centre de recherche Etienne-Le Bel
Principal Investigator: Jacques Jolivet, MD CSSS St-Jérome
  More Information

No publications provided

Responsible Party: Oncozyme Pharma Inc.
ClinicalTrials.gov Identifier: NCT01378143     History of Changes
Other Study ID Numbers: OP-103-C
Study First Received: June 15, 2011
Last Updated: October 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by Oncozyme Pharma Inc.:
Colorectal Cancer
Pentamidine bis(2-hydroxyethanesulfonate)
OCZ103-OS
Standard of Care

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

ClinicalTrials.gov processed this record on November 20, 2014