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

Open to recruitment Nov 2009
Target recruitment: 32. Planned recruitment completion: Dec 2010
Current recruitment: 10 patients (Jun 2010)
Active sites: 1 (Jun 2010)

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)]

PRIMARY OBJECTIVES

Primary Objective

Primary Objective (Stage 1): Test and refine dose adaptation algorithm to allow maximum dose without unacceptable levels of toxicity

Primary Objective (Stage 2): 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.

a) Obtain descriptive information on the advice generated by the system.

b) Obtain descriptive information on amount and duration of drug delivery (stage 2 only).

c) Obtain feedback from staff and patients on using the system.

d) Test and refine the mobile phone and server software systems.

e) Patient Experience Evaluation.

f) 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