Clinical trial NCT00559858: Pyridoxine in Preventing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine for Advanced Colorectal Cancer or Breast Cancer
Official title: A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Colorectal Cancer
Palmar-plantar Erythrodysesthesia
Keywords: palmar-plantar erythrodysesthesia
breast cancer
male breast cancer
colon cancer
rectal cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-16
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity
Secondary outcomes:
measure: Incidence of hand-foot syndrome (HFS)
measure: Overall toxicity
measure: Quality of life
measure: Response to chemotherapy
measure: Progression-free survival
measure: Measurement of biomarkers that might predict the occurrence of HFS
Other outcomes:
Locations:
city: Basildon
country: United Kingdom
facility: Basildon University Hospital
state: England
city: Bedford
country: United Kingdom
facility: Primrose Oncology Unit
state: England
city: Bury St. Edmunds
country: United Kingdom
facility: West Suffolk Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
state: England
city: Canterbury
country: United Kingdom
facility: Kent and Canterbury Hospital
state: England
city: Derby
country: United Kingdom
facility: Derbyshire Royal Infirmary
state: England
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital
state: England
city: King's Lynn
country: United Kingdom
facility: Queen Elizabeth Hospital
state: England
city: Lancanshire
country: United Kingdom
facility: Royal Albert Edward Infirmary
state: England
city: Maidstone
country: United Kingdom
facility: Mid Kent Oncology Centre at Maidstone Hospital
state: England
city: Peterborough
country: United Kingdom
facility: Peterborough Hospitals Trust
state: England
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
state: England
city: Swindon
country: United Kingdom
facility: Great Western Hospital
state: England
city: Tunbridge Wells
country: United Kingdom
facility: Kent and Sussex Hospital
state: England
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
state: England
city: Westcliff-On-Sea
country: United Kingdom
facility: Southend University Hospital NHS Foundation Trust
state: England
Study officials:
affiliation: Cambridge University Hospitals NHS Foundation Trust
name: Pippa Corrie, PhD, FRCP
role: STUDY_CHAIR
References: