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The p53 Colorectal Cancer Trial

Sponsor
Haukeland University Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT03149679
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
39
Actual Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial
Actual Study Start Date :
May 9, 2017
Actual Primary Completion Date :
Aug 7, 2020
Actual Study Completion Date :
Aug 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cyclophosphamide arm

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

Drug: Cyclophosphamide
Chemotherapy
Other Names:
  • Sendoxan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [4 months]

      Partial response (PR) or complete response (CR) as defined by the RECIST criteria

    Secondary Outcome Measures

    1. Possible molecular markers of therapy response/resistance and survival outcome beyond TP53 mutations will be examined. [10 years]

      Tissue and blood sampling at baseline and whenever treatment is changed

    2. Number of patients with treatment response among patients harboring TP53 mutations belonging to particular mutation subgroups [10 years]

      Tissue and blood sampling at baseline and whenever treatment is changed

    3. Clinical benefit rate (CBR) [5 years]

      Stable disease (SD) >6 months, PR or CR

    4. Recurrence-free and overall survival, compared to historical data [All patients will be followed for 5 years or until death to record survival outcome]

      Survival analyses

    5. Safety and tolerability of the study treatment including recording of number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Every second week during the treatment period from start of treatment, and thereafter every second month for 5 years or until death]

      Clinical examination and blood samples

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Haukeland University Hospital Bergen Norway 5021

    Sponsors and Collaborators

    • Haukeland University Hospital

    Investigators

    • Principal Investigator: Inger Marie Løes, MD PhD, Haukeland University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Haukeland University Hospital
    ClinicalTrials.gov Identifier:
    NCT03149679
    Other Study ID Numbers:
    • 2016/1637
    First Posted:
    May 11, 2017
    Last Update Posted:
    Jan 22, 2021
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Haukeland University Hospital
    Cyclophosphamide
    Colorectal Cancer Metastatic
    TP53 Gene Mutation
    Additional relevant MeSH terms:
    Colorectal Neoplasms
    Cyclophosphamide

    Study Results

    No Results Posted as of Jan 22, 2021