Colorectal CancerPhase 2NCT00028015
SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
A Phase 2 study testing SarCNU in people with Colorectal Cancer, run by NCIC Clinical Trials Group at 7 sites in Canada.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- SarCNU
- How many people
- 18 participants
- Where
- 7 sitesCanada
- Study dates
- 30 Oct 2001to 22 Sep 2008
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed colorectal cancer
- Locally recurrent or metastatic disease
- Previously treated with 1 chemotherapy regimen for recurrent or metastatic disease
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
- No prior radiotherapy to indicator lesion (clear disease progression or new lesion within a prior radiation port is acceptable)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 120,000/mm^3
Hepatic:
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Pulmonary:
- DLCO at least 80% predicted
- FVC at least 80% predicted
- No history of significant pulmonary disease
- No concurrent symptomatic pulmonary disease (e.g., chronic obstructive pulmonary disorder, chronic asthma)
Other:
- No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- No other serious illness or medical condition that would preclude study
- No ongoing or active uncontrolled infection
- No history of significant neurologic or psychiatric disorder that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 4 weeks since prior immunotherapy
- No concurrent immunotherapy
Chemotherapy:
- See Disease Characteristics
- Prior adjuvant chemotherapy allowed
- No prior nitrosoureas
- No prior second-line chemotherapy for recurrent or metastatic disease
- At least 4 weeks since prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent corticosteroids
Radiotherapy:
- See Disease Characteristics
- Prior radiotherapy as part of primary therapy allowed
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Prior surgery as part of primary therapy allowed
- Prior reoperation for recurrent disease allowed
- At least 2 weeks since prior surgery other than biopsy
Other:
- At least 4 weeks since prior investigational agent
- No other concurrent investigational agents or therapy
- No other concurrent anticancer therapy
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
Kingston Regional Cancer Centre
Kingston, Ontario, K7L 5P9
Hopital Notre- Dame du CHUM
Montreal, Quebec, H2L 4MI
McGill University
Montreal, Quebec, H2W 1S6
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 1C4
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
Official title: A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
Read the detailed description
OBJECTIVES:
- Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer.
- Determine the qualitative and quantitative toxicity of this drug in these patients.
- Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
- Conditions
- Colorectal Cancer
- Being tested
- SarCNU
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarCNUDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start30 Oct 2001
- Primary completion22 Sep 2003
- Study completion22 Sep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NCIC Clinical Trials Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Ralph PW Wong, MD, FRCPC, Study chair, CancerCare Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028015
- Sponsor's protocol ID
- I146
- Other IDs
- CAN-NCIC-IND146, CDR0000069113
- Status last verified
- Apr 2020
- First submitted
- 7 Dec 2001
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong RP, Baetz T, Krahn MJ, Biagi J, Wainman N, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. SarCNU in recurrent or metastatic colorectal cancer: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. Invest New Drugs. 2006 Jul;24(4):347-51. doi: 10.1007/s10637-006-5730-2.
PubMed 16502354
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00028015
- Acronym / sponsor ID
- I146
- Conditions
- Colorectal Cancer
- Keywords
- stage IV colon cancer, stage IV rectal cancer, recurrent colon cancer, recurrent rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NCIC Clinical Trials GroupResearch network
- Study start
- 30 Oct 2001 (actual)
- Primary completion
- 22 Sep 2003 (actual)
- Study completion
- 22 Sep 2008 (actual)
- First posted
- 27 Jan 2003 (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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
Detailed description
OBJECTIVES:
- Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer.
- Determine the qualitative and quantitative toxicity of this drug in these patients.
- Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR.
Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| SarCNU | Drug | – |
Primary outcome
Not reported in the source record.
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 9 Apr 2020.
- Results publication: PubMed 16502354Wong RP, Baetz T, Krahn MJ, Biagi J, Wainman N, Eisenhauer E; National Cancer Institute of Canada Clinical Trials Group. SarCNU in recurrent or metastatic colorectal cancer: a phase II study of the National Cancer Institute of Canada Clinical Trials Group. Invest New Drugs. 2006 Jul;24(4):347-51. doi: 10.1007/s10637-006-5730-2.
- Individual participant dataSharing planned: No
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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.
Ralph PW Wong, MD, FRCPC study chair
CancerCare Manitoba
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 SarCNU in people with Colorectal Cancer, run by NCIC Clinical Trials Group 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?
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 9 Apr 2020. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00028015, which also lists 1 linked publication.
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 9 Apr 2020.