The p53 Colorectal Cancer Trial | NCT03149679

Studies
The p53 Colorectal Cancer Trial

NCT03149679

Sponsor

Haukeland University Hospital

Status

Terminated

Last Update Posted

Jan 22, 2021Actual

Enrollment

12Actual

Phase

Phase 2

Conditions

Colorectal Cancer Metastatic
Colorectal Cancer Stage IV
TP53 Gene Mutation

Interventions

Cyclophosphamide

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2020

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.

Expanded Access Info

Start Date

May 9, 2017Actual

Primary Completion Date

Aug 7, 2020Actual

Completion Date

Aug 7, 2020Actual

First Submitted Date

Mar 14, 2017

First Submission Date that Met QC Criteria

May 9, 2017

First Posted Date

May 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 20, 2021

Last Update Posted Date

Jan 22, 2021Actual

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
Cyclophosphamide arm	Experimental	Dose dense cyclophosphamide (1800 Mg/m2) administered intravenously every second week.	Drug: Cyclophosphamide

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide	Drug	Chemotherapy	Cyclophosphamide arm	Sendoxan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective response rate (ORR)	Partial response (PR) or complete response (CR) as defined by the RECIST criteria	4 months

Secondary Outcomes

Measure	Description	Time Frame
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	10 years
Number of patients with treatment response among patients harboring TP53 mutations belonging to particular mutation subgroups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Inger Marie Løes, MD PhD	Haukeland University Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen		5021	Norway

ID	Term
D015179	Colorectal Neoplasms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

ID	Term
D003520	Cyclophosphamide

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Intervention 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.