pyridoxine and topical urea/lactic acid-based cream in preventing hand-foot syndrome in patients receiving capecitabine for breast cancer or other cancer

Conditions: Breast Cancer; Drug/Agent Toxicity by Tissue/Organ; Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: pyridoxine (vitamin b6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. it is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome. purpose: this randomized phase iii trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer.

objectives: * determine whether the prophylactic use of a topical urea/lactic acid cream can decrease the incidence/severity of capecitabine-caused palmar-plantar erythrodysesthesia in patients receiving capecitabine for breast and/or other cancer. * evaluate the potential toxicity of this cream. * determine whether the prophylactic use of vitamin b6 can decrease the incidence and/or severity of capecitabine-caused palmar-plantar erythrodysesthesia. * evaluate the potential toxicity of vitamin b6. * determine whether the prophylactic use of a topical urea/lactic acid cream in combination with vitamin b6 can decrease the incidence and/or severity of capecitabine caused palmar-plantar erythrodysesthesia. outline: this is a randomized, double-blind, placebo-controlled study. patients are stratified according to age (\ 60 years old), sex, capecitabine dose level (2000 mg/day vs 2500 mg/day), cancer type (breast vs other), and mode of therapy (adjuvant \[including neo-adjuvant\] therapy vs metastatic disease). patients are randomized to 1 of 6 treatment arms (treatment arms i-iv closed to accrual as of 10/24/007). * arm i (closed to accrual as of 10/24/2007): patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily and oral pyridoxine once daily on days 1-21. * arm ii (closed to accrual as of 10/24/2007): patients receive topical urea/lactic acid-based cream as in arm i (closed to accrual as of 10/24/2007) and oral placebo once daily on days 1-21. * arm iii (closed to accrual as of 10/24/2007): patients receive placebo cream applied to palms and soles twice daily and pyridoxine as in arm i (closed to accrual as of 10/24/2007). * arm iv (closed to accrual as of 10/24/2007):patients receive placebo cream as in arm iii and oral placebo as in arm ii (closed to accrual as of 10/24/2007). * arm v: patients receive topical urea/lactic acid-based cream applied to palms and soles twice daily on days 1-21. * arm vi: patients receive placebo cream applied to palms and soles twice daily on days 1-21. in all arms, treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
disease characteristics: * histologically confirmed breast and/or other cancer * undergoing first treatment with capecitabine as adjuvant (including neo-adjuvant) therapy or for metastatic disease * receiving a dose of capecitabine either 2,000 mg/day (1,000 mg twice daily) or 2,500 mg/day for 14 days with 4 courses of therapy at 3 week (+/- 3 days) intervals * hormone-receptor status not specified patient characteristics: * male or female * menopausal status not specified * no history of allergy to urea-containing cream * no pre-existing neuropathy ≥ grade 2 * 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: * no other concurrent agents that function to prevent palmar-plantar erythrodysesthesia caused by capecitabine or topical agents in the hands or feet for other indications (e.g., dryness) * no concurrent vitamin b6 \> 50 mg/day * no concurrent or planned use of over-the-counter products that contain urea or lactic acid, including any of the following: * aqua care® * medicated calamine\^® lotion (0.3%) * coppertone\^® waterproof ultra protection sunblock * dr. scholl's\^® smooth touch deep moisturizing cream * depicure\^® so smooth cream * dove\^® moisturizing cream wash * cetaphil\^ ®moisturizing cream * vaseline intensive care \^ ® lotion

Keywords: drug/agent toxicity by tissue/organ stage i breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer unspecified adult solid tumor, protocol specific