Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	18 and over	NCI, Pharmaceutical / Industry	NCCTG-N05C5 ROCHE-NCCTG-N05C5, NCT00296036

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.

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		2009-12-31 (estimated)
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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