The p53 Colorectal Cancer Trial

• Status: Terminated
• Trial end date: 2020-08-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Cyclophosphamide

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.