Clinical trial · Interventional
The p53 Colorectal Cancer Trial
Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer Metastatic | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Colorectal Cancer Stage IV | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| TP53 Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide arm
- description
- Dose dense cyclophosphamide (1800 Mg/m2) administered intravenously every second week.
- interventionNames
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- 4 months
- description
- Partial response (PR) or complete response (CR) as defined by the RECIST criteria
Secondary outcomes (5)
- measure
- Possible molecular markers of therapy response/resistance and survival outcome beyond TP53 mutations will be examined.
- timeFrame
- 10 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available