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

NCT01378143 | Completed Phase 2 DMC

• 1 other identifier: OP-103-C
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Pentamidine bis(2-hydroxyethanesulfonate); OCZ103-OS; Standard of Care

Outcome Measures

Primary Outcomes (3)

• Tumor size (CT scan)

  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

  2 years

• Progression free survival (PFS)

  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

  2 years

• Overall survival (OS)

  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

  2 years

Secondary Outcomes (4)

• Peak plasma concentration (Cmax) of OCZ103-OS

  2 months

• Number of participants with Adverse Events (AE) as a Measure of Safety and Tolerability

  2 years

• Objective response (OR)

  2 years

• Duration of response (DR)

  2 years

Study Arms (1)

OCZ103-OS, mFOLFOX6 or FOLFIRI

EXPERIMENTAL

OCZ103-OS in combination with mFOLFOX6 or FOLFIRI as standard of care

Drug: OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI

Interventions

OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI DRUG

OCZ103-OS is given in combination with Chemotherapy each cycle

OCZ103-OS, mFOLFOX6 or FOLFIRI

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/rectum with evidence of (1) unresectable and, locally recurrent, or (2) metastatic disease.
• Failure of first-line therapy(5-Fu-based therapy +/- bevacizumab) for metastatic colorectal cancer.
• At least one (1) unidimensionally 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), 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
• Total serum bilirubin ≤ 1.5 x ULN
• Lipase and amylase within normal limits or abnormal limits but deemed not clinically significant.
• Absolute neutrophil count (ANC) ≥ 1500/µL (1.5 x 10e9/L)
• Platelets ≥ 100,000/µL (100 x 10e9/L)
• Hemoglobin ≥ 90 g/L
• 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.
• Normal or abnormal ECG. If ECG shows abnormalities, they must be deemed not clinically significant.

You may not qualify if:

• Systolic Blood Pressure \<100 mmHg (if deemed clinically significant by the treating physician).
• Uncontrolled diabetes, severe renal impairment or pancreatitis.
• Concomitant therapy with other investigational agents or participation in another clinical trial within 30 days prior to enrollment.
• 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).
• Active uncontrolled bacterial infection.
• 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).
• 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.
• Concurrent use of drugs such as Rifampine and Lamivudine, since these that may be associated with pancreatitis.
• 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.
• Clinically significant non-malignant 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.
• Use of oral anticoagulants (LMWH is acceptable)

Sponsors & Collaborators

• Oncozyme Pharma Inc.: lead

Study Sites (7)

CSSS Champlain - Charles-Lemoyne Hospital

Greenfield Park, Quebec, J4V 2H1, Canada

Location

CSSS Alphonse-Desjardins (CHAU Hotel-Dieu de Levis)

Lévis, Quebec, Canada

Location

CHUM-St. Luc Hospital

Montreal, Quebec, H2X 3J4, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CHUS-Centre de recherche Etienne-Le Bel

Sherbrooke, Quebec, J1H 5N4, Canada

Location

CSSS St-Jérome

St-Jérome, Quebec, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 22, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 21, 2014

Record last verified: 2013-02

Locations

CA (7)