DATACAP

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

Chief Investigator: Dr Andrew Weaver

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

Oncology Clinical Trial Office (OCTO)

General Enquiries

Tel: +44 (0)1865 617003, Fax +44 (0)1865 617010

Email: DATACAP@octo-oxford.org.uk

Website: www.octo-oxford.org.uk