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

NHS Foundation Trust

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer; Palmar-plantar Erythrodysesthesia; Colorectal Cancer

Treatments: Dietary Supplement: pyridoxine hydrochloride; Procedure: quality-of-life assessment; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00559858

CDR0000576453 (Registry Identifier)

ISRCTN82842634

EUDRACT-2004-000325-29

CCLG-CAPP-IT

CRCA-CCTC-CAPP-IT

EU-20786

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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