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

Alternate Title

Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who are Receiving Capecitabine For Metastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Active 18 to 75 NCI, Pharmaceutical / Industry UCSF-057514 UCSF 057514, ROCHE-UCSF-057514, NCT00751101

Objectives

Primary

1. Determine the feasibility of using nicotine patches, in terms of side effects and the number of voluntary withdrawals from the study, in patients with metastatic breast cancer undergoing chemotherapy with capecitabine.

Secondary

1. Determine the efficacy of nicotine patches as preventive agents for hand-foot syndrome (HFS) by assessing the incidence of HFS in each arm.
2. Determine the grade of HFS in each arm.
3. Determine the percentage of patients requiring a reduction in dose of capecitabine due to adverse events.
4. Determine the percentage of patients requiring pain medication for HFS.
5. Determine the percentage of patients using other symptomatic treatments for HFS (e.g., moisturizers, ice, cooling packs).
6. Evaluate the effect of nicotine patches on quality-of-life of patients undergoing capecitabine chemotherapy.

Entry Criteria

Disease Characteristics:

• Diagnosis of breast cancer
  • Metastatic disease



• Scheduled to begin treatment with capecitabine at the UCSF Cancer Center, San Francisco General Hospital, or Cornell Medical Center



• No concurrent hand-foot syndrome (HFS) due to other medications
  • Prior HFS due to other medications allowed provided that the symptoms have been completely resolved for ≥ 4 weeks prior to study entry



• Hormone receptor status not specified

Prior/Concurrent Therapy:

• At least 6 months since prior and no other concurrent nicotine patches
• Prior chemotherapy allowed, except capecitabine for treatment of metastatic disease
• Concurrent other symptomatic treatment for hand-foot syndrome (HFS) (e.g., usual skin care, topical moisturizers, ice packs, pain medications) allowed
• No concurrent pyridoxine

Patient Characteristics:

• Menopausal status not specified
• ECOG performance status 0-2
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 6 months after completion of study therapy
• Able to participate in study procedures and quality-of-life evaluations and willing to comply with study requirements
• Non-English speaking patients are allowed provided they demonstrate adequate understanding of the study rationale and procedures and can give voluntary consent with the aid of a translator
• No clinically significant cardiac or peripheral vascular disease or symptom, including any of the following:
  • History of myocardial infarction
  • Congestive heart failure
  • Cardiac arrhythmias (including atrial fibrillation)
  • Cardiac or vascular bypass
  • Uncontrolled hypertension
  • Unstable angina
  • Undiagnosed arrhythmias or claudication
• No Alzheimer disease, Parkinson disease, or active psychiatric disease
• Not currently smoking
  • Patients who are former smokers must have stopped smoking ≥ 6 months prior to study entry
• No known hypersensitivity to nicotine patches

Expected Enrollment

Outcomes

Incidence and severity of hand-foot syndrome (HFS) as measured by NCI CTCAE v3.0

Side effects of the transdermal nicotine patch as measured by NCI CTCAE v3.0
Compliance in using the transdermal nicotine patch as measured by patient diary
Percentage of patients requiring dose reduction of capecitabine due to any side effects
Use of pain medication and other symptomatic treatments for HFS
Quality of life as measured by FACT-B scale

Outline

This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Patients receive oral capecitabine twice daily on days 1-7 and 15-21. Treatment with capecitabine repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.

• Arm I: Patients apply a transdermal nicotine patch once every 24 hours beginning on 1 day prior to initiation of capecitabine and continuing until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.



• Arm II: Patients apply a transdermal nicotine patch once every 24 hours beginning on day 1 of the course of chemotherapy following the appearance of hand-foot syndrome symptoms. Treatment continues until the end of capecitabine therapy in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, and at 3 and 12 weeks. Patients also complete a daily diary to document side effects and medication compliance.

After completion of study therapy, patients are followed at 3 weeks.

Trial Contact Information

Trial Lead Organizations

UCSF Helen Diller Family Comprehensive Cancer Center

Hope Rugo, MD, Principal investigator		Ph: 415-353-7428; 800-888-8664 Email: hrugo@medicine.ucsf.edu

U.S.A.
California
	San Francisco
	UCSF Helen Diller Family Comprehensive Cancer Center
		Clinical Trials Office - UCSF Helen Diller Family Comprehensive Cancer Center	Ph:  877-827-3222

Registry Information
Official Title		Pilot Study of Nicotine Patches to Reduce Hand-Foot Syndrome associated with Capecitabine Chemotherapy in Patients with Metastatic Breast Cancer
Trial Start Date		2007-08-20
Trial Completion Date		2010-12-20 (estimated)
Registered in ClinicalTrials.gov		NCT00751101
Date Submitted to PDQ		2008-08-29
Information Last Verified		2008-09-11
NCI Grant/Contract Number		CA821063