Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer (NCT00486213) | Clinical Trial Compass
TerminatedPhase 3
Pyridoxine in Preventing Hand-Foot Syndrome Caused by Capecitabine in Patients With Cancer
Stopped: Slow accrual
Singapore210 participantsStarted 2007-06
Plain-language summary
RATIONALE: Pyridoxine may help prevent hand-foot syndrome caused by capecitabine in patients with cancer. It is not yet known whether pyridoxine is more effective than a placebo in preventing hand-foot syndrome in patients with cancer.
PURPOSE: This randomized phase III trial is studying pyridoxine to see how well it works compared with a placebo in preventing hand-foot syndrome caused by capecitabine in patients with cancer.
Who can participate
Age range18 Years
SexALL
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DISEASE CHARACTERISTICS:
* Diagnosis of cancer
* Must be receiving single-agent capecitabine either in the adjuvant/neoadjuvant or palliative setting at a dose of ≥ 1000 mg/m² twice daily on days 1-14 (given in 3-week courses)
PATIENT CHARACTERISTICS:
* Life expectancy \> 12 weeks
* No preexisting neuropathy
* No known allergy to pyridoxine hydrochloride and its incipients
* No other dermatologic condition that, in the opinion of the physician, may affect the hands or feet or may complicate evaluation during study treatment
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior capecitabine
* Concurrent radiotherapy, steroids, and/or biological therapy (e.g., trastuzumab \[Herceptin®\] or bevacizumab) allowed provided they do not cause hand-foot syndrome (HFS)
* No other concurrent drugs (e.g., docetaxel or doxorubicin hydrochloride liposome) that can cause HFS
* No concurrent drugs (e.g., oxaliplatin or taxanes) that can cause neuropathy
* No concurrent pyridoxine hydrochloride-containing preparations (e.g., multivitamins or vitamin B complex)
* No concurrent over-the-counter products that contain urea or lactic acid
* No concurrent drugs reported to have drug interactions with pyridoxine hydrochloride (e.g., cycloserine; hydralazine; immunosuppressants; isoniazid; levodopa; estrogen or estrogen-containing contraceptives; penicillamine; phenobarbitone; phenytoin; or pyrazinamide)
What they're measuring
1
First incidence of hand-foot syndrome (HFS) ≥ grade 2 according to NCI CTCAE vs 3.0