A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
18 Years
N/A
Both
Breast Cancer, Colorectal Cancer, Palmar-Plantar Erythrodysesthesia
Trial Information
A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Outcome Measure:
Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
Principal Investigator
Pippa Corrie, PhD, FRCP
Investigator Role:
Study Chair
Investigator Affiliation:
Cambridge University Hospitals NHS Foundation Trust
Authority:
United States: Federal Government
Study ID:
CDR0000576453
NCT ID:
NCT00559858
Start Date:
December 2004
Completion Date:
Related Keywords:
- Breast Cancer
- Colorectal Cancer
- Palmar-Plantar Erythrodysesthesia
- palmar-plantar erythrodysesthesia
- breast cancer
- male breast cancer
- colon cancer
- rectal cancer
- Breast Neoplasms
- Colorectal Neoplasms
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