Colorectal Cancer Metastatic Clinical Trial
Official title:
Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial
Verified date | February 2020 |
Source | Haukeland University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | August 7, 2020 |
Est. primary completion date | August 7, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University Hospital | Bergen |
Lead Sponsor | Collaborator |
---|---|
Haukeland University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate (ORR) | Partial response (PR) or complete response (CR) as defined by the RECIST criteria | 4 months | |
Secondary | 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 | |
Secondary | Number of patients with treatment response among patients harboring TP53 mutations belonging to particular mutation subgroups | Tissue and blood sampling at baseline and whenever treatment is changed | 10 years | |
Secondary | Clinical benefit rate (CBR) | Stable disease (SD) >6 months, PR or CR | 5 years | |
Secondary | Recurrence-free and overall survival, compared to historical data | Survival analyses | All patients will be followed for 5 years or until death to record survival outcome | |
Secondary | Safety and tolerability of the study treatment including recording of number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Clinical examination and blood samples | Every second week during the treatment period from start of treatment, and thereafter every second month for 5 years or until death |
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