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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00559858
First received: November 15, 2007
Last updated: August 1, 2013
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Colorectal Cancer
Palmar-plantar Erythrodysesthesia
Dietary Supplement: pyridoxine hydrochloride
Other: placebo
Procedure: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Randomised Placebo-controlled Study Evaluating the Role of Pyridoxine in Controlling Capecitabine-induced Hand-foot Syndrome

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence of capecitabine dose modifications (dose delay and dose reductions) due to toxicity

Secondary Outcome Measures:
  • Incidence of hand-foot syndrome (HFS)
  • Overall toxicity
  • Quality of life
  • Response to chemotherapy
  • Progression-free survival
  • Measurement of biomarkers that might predict the occurrence of HFS

Estimated Enrollment: 270
Study Start Date: December 2004
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559858

Locations
United Kingdom
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
Primrose Oncology Unit
Bedford, England, United Kingdom, MK42 9DJ
West Suffolk Hospital
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT2 7NR
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Queen Elizabeth Hospital
King's Lynn, England, United Kingdom, PE30 4ET
Royal Albert Edward Infirmary
Lancanshire, England, United Kingdom, WN1 2NN
Mid Kent Oncology Centre at Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Peterborough Hospitals Trust
Peterborough, England, United Kingdom, PE3 6DA
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Great Western Hospital
Swindon, England, United Kingdom, SN3 6BB
Kent and Sussex Hospital
Tunbridge Wells, England, United Kingdom, TN4 8AT
Walsall Manor Hospital
Walsall, England, United Kingdom, WS2 9PS
Southend University Hospital NHS Foundation Trust
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Investigators
Study Chair: Pippa Corrie, PhD, FRCP Cambridge University Hospitals NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00559858     History of Changes
Other Study ID Numbers: CRCA-CCTC-CAPP-IT, CDR0000576453, EUDRACT-2004-000325-29, EU-20786, ISRCTN82842634, CCLG-CAPP-IT
Study First Received: November 15, 2007
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
palmar-plantar erythrodysesthesia
breast cancer
male breast cancer
colon cancer
rectal cancer

Additional relevant MeSH terms:
Breast Neoplasms
Colorectal Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pyridoxine
Vitamin B 6
Pyridoxal
Capecitabine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014