Colorectal Cancer MetastaticPhase 2NCT03149679
The p53 Colorectal Cancer Trial
A Phase 2 study testing Cyclophosphamide in people with Colorectal Cancer Metastatic and Colorectal Cancer Stage IV, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Colorectal Cancer Stage IV, TP53 Gene Mutation
- What is being tested?
- Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNorway
- Study dates
- 9 May 2017to 7 Aug 2020
- 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
- Metastatic colorectal cancer patients for whom conventional therapy has failed; defined as 2 lines of chemotherapy including oxaliplatin or irinotecan- containing regimens as well as an EGFR inhibitor if applicable.
- Tumor lesion suitable for biopsy
- Age >18 years
- Clinically or radiologically measurable tumor deposits according to the RECIST criteria
- WHO performance status 0-1
- Radiology studies (CT thorax/abdomen/pelvis) and echo cor and ECG must be performed within 28 days prior to registration.
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- Before patient registration in the trial, written informed consent must be given according to national and local regulations.
- Blood test requirements:
- Neutrophils > 1.0 e9/L Platelets > 75 e9/L Bilirubin < 20 µmol / L. Serum creatinine < 1.5 x ULN
Who cannot join
- Co-morbidity including, but not limited to, impaired renal-, liver or bone marrow function, that based on the assessment of the treating physician, may preclude the use of cyclophosphamide at actual doses.
- Known hypersensitivity to the study drug, its metabolites or any excipients in the infusion solution.
- Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Pregnant or lactating patients cannot be included.
- Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
- Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial
Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm.
- Being tested
- Cyclophosphamide
- Keywords
- Cyclophosphamide, Colorectal Cancer Metastatic, TP53 Gene Mutation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Sendoxan
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide arm | Experimental | Dose dense cyclophosphamide (1800 Mg/m2) administered intravenously every second week. Receives: Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Partial response (PR) or complete response (CR) as defined by the RECIST criteria
Measured: 4 months
Secondary outcomes (5)
Possible molecular markers of therapy response/resistance and survival outcome beyond TP53 mutations will be examined.
Tissue and blood sampling at baseline and whenever treatment is changed
Measured: 10 years
Number of patients with treatment response among patients harboring TP53 mutations belonging to particular mutation subgroups
Tissue and blood sampling at baseline and whenever treatment is changed
Measured: 10 years
Clinical benefit rate (CBR)
Stable disease (SD) >6 months, PR or CR
Measured: 5 years
Recurrence-free and overall survival, compared to historical data
Survival analyses
Measured: All patients will be followed for 5 years or until death to record survival outcome
Safety and tolerability of the study treatment including recording of number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Clinical examination and blood samples
Measured: Every second week during the treatment period from start of treatment, and thereafter every second month for 5 years or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start9 May 2017
- Primary completion7 Aug 2020
- Study completion7 Aug 2020
Why it stopped: The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Model description
- Single center, open labeled, phase 2 clinical trial, where patients are selected for treatment based on upfront TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the single treatment arm. The informed consent, however needs to be signed prior to a biopsy for TP53 mutation analyses; thus, all patients are formally enrolled in the study prior to tissue collection, and the full population tested will be accounted for despite the fact that only patients with TP53 mutated tumors may enter the single treatment arm.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Inger Marie Løes, MD PhD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149679
- Sponsor's protocol ID
- 2016/1637
- Status last verified
- Feb 2020
- First submitted
- 14 Mar 2017
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial
- ClinicalTrials.gov ID
- NCT03149679
- Acronym / sponsor ID
- 2016/1637
- Keywords
- Cyclophosphamide, Colorectal Cancer Metastatic, TP53 Gene Mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 7 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 11 May 2017 (actual)
- 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.
Single center, open labeled, phase 2 clinical trial, where patients with metastatic colorectal cancer are selected for treatment with dose dense Cyclophosphamide every second week based on TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the treatment arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, open labeled, phase 2 clinical trial, where patients are selected for treatment based on upfront TP53 mutation status; i.e. only patients with TP53 mutated tumors may be included in the single treatment arm. The informed consent, however needs to be signed prior to a biopsy for TP53 mutation analyses; thus, all patients are formally enrolled in the study prior to tissue collection, and the full population tested will be accounted for despite the fact that only patients with TP53 mutated tumors may enter the single treatment arm.
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide arm | Experimental | Drug: CyclophosphamideDose dense cyclophosphamide (1800 Mg/m2) administered intravenously every second week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Metastatic colorectal cancer patients for whom conventional therapy has failed; defined as 2 lines of chemotherapy including oxaliplatin or irinotecan- containing regimens as well as an EGFR inhibitor if applicable.
- Tumor lesion suitable for biopsy
- Age >18 years
- Clinically or radiologically measurable tumor deposits according to the RECIST criteria
- WHO performance status 0-1
Key exclusion criteria (6 listed)
- Co-morbidity including, but not limited to, impaired renal-, liver or bone marrow function, that based on the assessment of the treating physician, may preclude the use of cyclophosphamide at actual doses.
- Known hypersensitivity to the study drug, its metabolites or any excipients in the infusion solution.
- Psychological, familial, sociological or geographical condition(s) potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Pregnant or lactating patients cannot be included.
- Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
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 |
|---|---|---|
| CyclophosphamideAlso: SendoxanChemotherapy | Drug | Cyclophosphamide arm |
Primary outcome
Objective response rate (ORR)
Time frame: 4 months
Partial response (PR) or complete response (CR) as defined by the RECIST criteria
5 secondary outcomes
Possible molecular markers of therapy response/resistance and survival outcome beyond TP53 mutations will be examined.
Time frame: 10 years
Number of patients with treatment response among patients harboring TP53 mutations belonging to particular mutation subgroups
Time frame: 10 years
Clinical benefit rate (CBR)
Time frame: 5 years
Recurrence-free and overall survival, compared to historical data
Time frame: All patients will be followed for 5 years or until death to record survival outcome
Safety and tolerability of the study treatment including recording of number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: Every second week during the treatment period from start of treatment, and thereafter every second month for 5 years or until death
Results and safety
The study was stopped early (reason given: The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- 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.
Inger Marie Løes, MD PhD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide in people with Colorectal Cancer Metastatic and Colorectal Cancer Stage IV, run by Haukeland University Hospital at 1 site in Norway.
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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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 was stopped early (reason given: The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.). Results are not available in the source record.
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?
Objective response rate (ORR) (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2021.