Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer

Last updated: August 1, 2013
Sponsor: Cambridge University Hospitals NHS Foundation Trust
Overall Status: Trial Status Unknown

Phase

3

Condition

Colorectal Cancer

Rectal Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00559858
CRCA-CCTC-CAPP-IT
EU-20786
CCLG-CAPP-IT
ISRCTN82842634
EUDRACT-2004-000325-29
CDR0000576453
  • Ages > 18
  • All Genders

Study Summary

RATIONALE: Pyridoxine (vitamin B6) may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome.

PURPOSE: This phase III randomized trial is studying pyridoxine to see how well it works compared to a placebo in preventing hand-foot syndrome in patients who are receiving capecitabine for advanced colorectal cancer or breast cancer.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS:

  • Diagnosis of advanced colorectal or breast carcinoma

  • Hormone receptor status not specified

  • Receiving single-agent capecitabine chemotherapy

  • Measurable disease for response assessment, determined on an individual patient basis, using conventional clinical and/or radiological methods

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2

  • Menopausal status not specified

  • Life expectancy ≥ 12 weeks

  • Hemoglobin ≥ 10 g/dL

  • Platelet count ≥ 100,000 mm^3

  • WBC ≥ 3,000/mm^3

  • ANC ≥ 1,500/mm^3

  • Bilirubin ≤ 1.3 x upper limit of normal (ULN)

  • Alkaline phosphatase ≤ 5 x ULN

  • AST and ALT ≤ 5 x ULN

  • Creatinine ≤ 1.5 x ULN

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective contraception during and for 3 months after completion of study treatment

  • No other serious or uncontrolled illness which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial

  • No medical or psychiatric condition which would influence the ability to provide informed consent

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • At least 6 weeks since prior investigational agents

  • Concurrent radiotherapy allowed

  • No other concurrent chemotherapy or immunotherapy

  • No concurrent nonsteroidal anti-inflammatory drugs NSAIDs) for the primary purpose of treating hand-foot syndrome (HFS) or cancer

  • NSAIDs for conditions other than HFS or cancer allowed

Study Design

Total Participants: 270
Study Start date:
December 01, 2004
Estimated Completion Date:

Study Description

OBJECTIVES:

Primary

  • Determine whether pyridoxine can reduce the incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity.

Secondary

  • Determine the incidence of hand-foot syndrome (HFS).

  • Determine the overall toxicity.

  • Determine the quality of life.

  • Determine the response to chemotherapy.

  • Determine the progression-free survival.

  • Determine the level of biomarkers which might predict the occurrence of HFS.

OUTLINE: This is a multicenter study. Patients are stratified according to disease (breast cancer vs colorectal cancer). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral pyridoxine hydrochloride 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.

  • Arm II: Patients receive oral placebo 3 times daily beginning with the initiation of capecitabine chemotherapy and continuing until completion of chemotherapy.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

Evidence of hand-foot syndrome is assessed at baseline and before each course of capecitabine. Quality of life is assessed at baseline and then every 6 weeks.

After completion of study treatment, patients are followed at 6 and 12 weeks.

Connect with a study center

  • Basildon University Hospital

    Basildon, England SS16 5NL
    United Kingdom

    Site Not Available

  • Primrose Oncology Unit

    Bedford, England MK42 9DJ
    United Kingdom

    Site Not Available

  • West Suffolk Hospital

    Bury St. Edmunds, England IP33 2QZ
    United Kingdom

    Site Not Available

  • Addenbrooke's Hospital

    Cambridge, England CB2 2QQ
    United Kingdom

    Site Not Available

  • Kent and Canterbury Hospital

    Canterbury, England CT2 7NR
    United Kingdom

    Site Not Available

  • Derbyshire Royal Infirmary

    Derby, England DE1 2QY
    United Kingdom

    Site Not Available

  • Royal Devon and Exeter Hospital

    Exeter, England EX2 5DW
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    King's Lynn, England PE30 4ET
    United Kingdom

    Site Not Available

  • Royal Albert Edward Infirmary

    Lancanshire, England WN1 2NN
    United Kingdom

    Site Not Available

  • Mid Kent Oncology Centre at Maidstone Hospital

    Maidstone, England ME16 9QQ
    United Kingdom

    Site Not Available

  • Peterborough Hospitals Trust

    Peterborough, England PE3 6DA
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, England PL6 8DH
    United Kingdom

    Site Not Available

  • Great Western Hospital

    Swindon, England SN3 6BB
    United Kingdom

    Site Not Available

  • Kent and Sussex Hospital

    Tunbridge Wells, England TN4 8AT
    United Kingdom

    Site Not Available

  • Walsall Manor Hospital

    Walsall, England WS2 9PS
    United Kingdom

    Site Not Available

  • Southend University Hospital NHS Foundation Trust

    Westcliff-On-Sea, England SS0 0RY
    United Kingdom

    Site Not Available

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