Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring Pilot Study of Optimal Dose Scheduling of Capecitabine for Patients With Metastatic Colorectal or Metastatic Breast Cancer
18 Years
N/A
Both
Metastatic Colorectal Cancer, Metastatic Breast Cancer
Trial Information
Dose Adaptation of Capecitabine Using Mobile Phone Toxicity Monitoring Pilot Study of Optimal Dose Scheduling of Capecitabine for Patients With Metastatic Colorectal or Metastatic Breast Cancer
Patients with metastatic colorectal or breast cancer will be recruited.
- Metastatic Colorectal Cancer: capecitabine alone or capecitabine + oxaliplatin for 8
3-week cycles
- Metastatic Breast Cancer: capecitabine alone or capecitabine + docetaxel for 8 3-week
cycles.
All patients will be given a mobile phone onto which they will enter any side-effects
experienced prior to taking capecitabine in the morning and evening. Any grade 3 or 4
symptoms will trigger an alert to a pager held by the ward-staff for immediate attention.
Thus, patients' severe side-effects will be monitored in real time and the trial will allow
real-time dose reductions during cycles and dose-increases at clinics. Patient experience in
the trial will also be evaluated during their participation in the trial.
Patients will already be receiving the drug prior to this study and will not be administered
to patients as part of this study.
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/m2d 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 Cockroft-Gault formula)]
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Toxicities (frequency at each of grades 2, 3 and 4, over all cycles)
Outcome Time Frame:
At the end of each cycle and at occurrence
Safety Issue:
Yes
Authority:
Oxfordshire research ethics committee A, country name: United Kingdom
Study ID:
Mobile Datacap
NCT ID:
NCT01053104
Start Date:
November 2009
Completion Date:
April 2011
Related Keywords:
- Metastatic Colorectal Cancer
- Metastatic Breast Cancer
- Colorectal cancer
- Breast cancer
- Capecitabine
- Docetaxel
- Mobile phone
- Toxicity
- Metastatic
- Breast Neoplasms
- Colorectal Neoplasms
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