The p53 Colorectal Cancer Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-09

Study Completion Date

2020-08-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Cancer Metastatic Colorectal Cancer Stage IV TP53 Gene Mutation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cyclophosphamide arm

Dose dense cyclophosphamide (1800 Mg/m2) administered intravenously every second week.

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Chemotherapy

Interventions

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Cyclophosphamide

Chemotherapy

Intervention Type DRUG

Other Intervention Names

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Sendoxan

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No