The p53 Colorectal Cancer Trial

Haukeland University Hospital

Status and phase

Terminated

Phase 2

Conditions

Colorectal Cancer Stage IV

TP53 Gene Mutation

Colorectal Cancer Metastatic

Treatments

Drug: Cyclophosphamide

Study type

Interventional

Funder types

Other

Identifiers

NCT03149679

2016/1637

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.