Colorectal CancerPhase 2NCT01378143

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

A Phase 2 study testing OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI in people with Colorectal Cancer, run by Oncozyme Pharma Inc. at 7 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer
What is being tested?: OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 7 sitesCanada
Study dates: Mar 2011to Jul 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).
18 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

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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.
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.
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.

Who cannot join

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).

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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)

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Canada7 sites

CSSS Champlain - Charles-Lemoyne Hospital
Greenfield Park, Quebec, J4V 2H1
CSSS Alphonse-Desjardins (CHAU Hotel-Dieu de Levis)
Lévis, Quebec
CHUM-St. Luc Hospital
Montreal, Quebec, H2X 3J4
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
CHUS-Centre de recherche Etienne-Le Bel
Sherbrooke, Quebec, J1H 5N4
CSSS St-Jérome
St-Jérome, Quebec

Other trials in Canada

About this study

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

Read the 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.

Conditions: Colorectal Cancer
Being tested: OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI
Keywords: Colorectal Cancer, Pentamidine bis(2-hydroxyethanesulfonate), OCZ103-OS, Standard of Care
Medical subject headings: Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRIDrug
OCZ103-OS is given in combination with Chemotherapy each cycle

Study groups in NCT01378143
Study group	Role	What they receive
OCZ103-OS, mFOLFOX6 or FOLFIRI	Experimental	OCZ103-OS in combination with mFOLFOX6 or FOLFIRI as standard of care Receives: Drug: OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 2 years

Secondary outcomes (4)

Peak plasma concentration (Cmax) of OCZ103-OS
- 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.
Measured: 2 months
Number of participants with Adverse Events (AE) as a Measure of Safety and Tolerability
- 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.
Measured: 2 years
Objective response (OR)
- 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.
Measured: 2 years
Duration of response (DR)
- 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.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Jul 2014

First posted22 Jun 2011 (estimated)
Study startMar 2011
Primary completionMar 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01378143
Sponsor's protocol ID: OP-103-C
Status last verified: Feb 2013
First submitted: 15 Jun 2011
Last updated: 21 Oct 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01378143
Acronym / sponsor ID: OP-103-C
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer, Pentamidine bis(2-hydroxyethanesulfonate), OCZ103-OS, Standard of Care
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Oncozyme Pharma Inc.Industry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Mar 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 22 Jun 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
OCZ103-OS, mFOLFOX6 or FOLFIRI	Experimental	Drug: OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRIOCZ103-OS in combination with mFOLFOX6 or FOLFIRI as standard of care

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

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).
18 years of age or older.
ECOG performance status 0, 1 or 2.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRIOCZ103-OS is given in combination with Chemotherapy each cycle	Drug	OCZ103-OS, mFOLFOX6 or FOLFIRI

Primary outcome

Tumor size (CT scan)
Time frame: 2 years
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
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
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

4 secondary outcomes

Peak plasma concentration (Cmax) of OCZ103-OS
Time frame: 2 months
Number of participants with Adverse Events (AE) as a Measure of Safety and Tolerability
Time frame: 2 years
Objective response (OR)
Time frame: 2 years
Duration of response (DR)
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2014.

Related trials for Colorectal Cancer

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Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Petr Kavan, MD, Ph.D. principal investigator

Jewish General Hospital

Benoit Samson, MD principal investigator

CSSS Champlain - Charles-Lemoyne Hospital

Richard Letourneau, MD principal investigator

St. Luc Hospital

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI in people with Colorectal Cancer, run by Oncozyme Pharma Inc. at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor size (CT scan) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01378143.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.