Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer

Basic Trial Information

Objectives

1. 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.
2. Evaluate the potential toxicity of this cream.
3. Determine whether the prophylactic use of vitamin B6 can decrease the incidence and/or severity of capecitabine-caused palmar-plantar erythrodysesthesia.
4. Evaluate the potential toxicity of vitamin B6.
5. 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.

Entry 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

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

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

Expected Enrollment

A total of 132 patients will be accrued for this study.

Outcomes

Percentage of patients with ≥ moderate hand and/or foot symptoms as assessed by patient daily diary vs physician

Percentage of patients with ≥ mild hand and/or foot symptoms as assessed by patient daily diary vs physician
Percentage of patients with ≥ severe hand and/or foot symptoms as assessed by patient daily diary vs physician
Mean maximum score of hand and/or foot symptoms as assessed by patient daily diary vs physician

Outline

This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to age (< 50 years old vs 50-60 years old vs > 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.

Wolf SL, Qin R, Menon SP, et al.: Evaluation of a urea/lactic acid-based topical keratolytic agent (ULABTKA) for prevention of capecitabine-induced hand and foot syndrome (HFS): NCCTG trial N05C5. [Abstract] J Clin Oncol 28 (Suppl 15): A-9017, 2010.

Wolf SL, Qin R, Menon SP, et al.: Placebo-controlled trial to determine the effectiveness of a urea/lactic acid-based topical keratolytic agent for prevention of capecitabine-induced hand-foot syndrome: North Central Cancer Treatment Group Study N05C5. J Clin Oncol 28 (35): 5182-7, 2010.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Charles Loprinzi, MD, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu
Jeffrey Berenberg, MD, Protocol co-chair		Ph: 808-586-3010

Registry Information
Official Title		A Phase III Randomized, Placebo-controlled, Double-blind Trial to Determine the Effectiveness of a Urea/Lactic Acid-Based Topical Keratolytic Agent and Vitamin B-6 for Prevention of Capecitabine-Induced Hand and Foot Syndrome
Trial Start Date		2006-06-23
Trial Completion Date		2010-06-23
Registered in ClinicalTrials.gov		NCT00296036
Date Submitted to PDQ		2006-01-09
Information Last Verified		2009-01-23
NCI Grant/Contract Number		CA37404

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