Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial
18 Years
N/A
Both
Breast Cancer, Palmar-plantar Erythrodysesthesia
Trial Information
Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial
OBJECTIVES:
- Evaluate the effects of F511 cream on the occurrence of palmar-plantar
erythrodysesthesia (PPE) in patients with metastatic breast cancer treated with
pegylated liposomal doxorubicin hydrochloride.
OUTLINE: This is a multicenter study.
Patients receive pegylated liposomal doxorubicin hydrochloride according to local practice
on 1, 2, or 4 weeks course schedules with at least 10 mg/m^2 per week allowed.
Patients apply F511 cream on one side, hand and foot and the corresponding placebo on the
other side hand and foot once daily (the morning) during the first week of the first
pegylated liposomal doxorubicin hydrochloride treatment only, then once daily, three times
per week thereafter. Treatment continues throughout chemotherapy administration in the
absence of palmar-plantar erythrodysesthesia (PPE) ≥ grade 2
After completion of study therapy, patients are followed for 30 days. Patients with PPE ≥
grade 2 are followed until the PPE resolves to ≤ grade 1.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic breast cancer
- No cutaneous metastases on hands or feet
- Pegylated liposomal doxorubicin hydrochloride monotherapy is indicated according to
the local investigator
- Planned dose at least 10 mg/m^2 per week
- No sign of palmar-plantar erythrodysesthesia (PPE) at study entry
PATIENT CHARACTERISTICS:
- WHO performance status 0-2
- Able to apply topical medication (cream) or provide for another person to apply cream
- Not pregnant or breastfeeding
- Fertile patients must use effective contraception during trial participation and for
1 month after completion
- Negative pregnancy test
- Compliant and geographically proximal in order to allow proper evaluation and
follow-up
- No dermatologic conditions (e.g., psoriasis) that, in the opinion of the physician,
may affect the hands or feet or may complicate evaluation during study treatment
- No known allergy or hypersensitivity to F511 cream
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 30 days since prior and no concurrent treatment with other experimental
drugs or anticancer therapy
- More than 30 days since prior and no concurrent treatment on another clinical trial
- No concurrent local use of other ointments or creams for hands or feet other than
Excipial Repair®
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Outcome Measure:
Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2
Outcome Time Frame:
Until PPE grade ≥2
Safety Issue:
No
Principal Investigator
Thomas Ruhstaller, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Kantonsspital St. Gallen
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 92/08
NCT ID:
NCT00992706
Start Date:
September 2009
Completion Date:
June 2012
Related Keywords:
- Breast Cancer
- Palmar-Plantar Erythrodysesthesia
- palmar-plantar erythrodysesthesia
- stage IV breast cancer
- male breast cancer
- Breast Neoplasms
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