Title

DATACAP

Chief Investigator: 
Andrew Weaver

 

Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring: A Pilot Study of Optimal Dose Scheduling of Capecitabine for Patients with Metastatic Colorectal or Metastatic Breast Cancer.

The aim of the study is to develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose. This is a single centre, pilot study which will be run at the Churchill Hospital in Oxford.

 

Study Status

Closed 
DATACAP has reached its target of 26 patients. 
Active sites: 1

Inclusion Criteria

  • Metastatic colorectal or breast cancer patients commencing treatment on one of four  specified regimens
         For metastatic colorectal cancer:
         - capecitabine 2000mg/ m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (CAPOX) 
         - capecitabine 2500mg/m2 d 1-14, q 3 weekly
 
        For metastatic breast cancer:
        - capecitabine 2000mg/m2 d 1-14, q 3 weekly 
        - capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3   weekly
  •  Age ≥ 18 years
  • Fit to start at full (100%) starting dose of all drugs
  • Able and willing to use mobile phone
  • Reasonable renal, liver and bone marrow function
                                - Absolute neutrophil count (ANC) >1.5 x 109/L 
                                - Platelet count > 100 x 109/L
                                - Total bilirubin < 1.5 ULN
                                - ALT, AST < 2.5 x ULN 
                                - Alkaline phosphatase < 2.5 x ULN
  • No obvious contra indications to capecitabine or oxaliplatin or docetaxel.
  • Patients must also be able to read, write and understand English.

Exclusion Criteria

  • Patients who live in an area of no Vodafone or Orange mobile phone network.
  • Patients participating in other cancer treatment trials.
  • Moderate or severe renal impairment [creatinine clearance <30ml/min (calculated according to the Cockroft-Gault formula)].

Study Objectives

Primary Objective in Stage 1:

  • To test and refine dose adaptation algorithm to allow maximum dose without unacceptable levels of toxicity.

Primary Objective in Stage 2:

  • To demonstrate high dose intensity and acceptable toxicity using dose-adaptation algorithm developed during stage 1.

Secondary Objectives:

  • These objectives are pertinent to both stages but will be reported separately for each stage.
  • Obtain descriptive information on the advice generated by the system.
  • Obtain descriptive information on amount and duration of drug delivery (stage 2 only).
  • Obtain feedback from staff and patients on using the system.
  • Test and refine the mobile phone and server software systems.
  • Patient Experience Evaluation.
  • Evaluate safety outcomes
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