F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
RATIONALE: F511 cream may prevent or reduce palmar-plantar erythrodysesthesia in women receiving doxorubicin hydrochloride liposome for metastatic breast cancer.
PURPOSE: This randomized phase III trial is studying F511 cream to see how well it works compared with a placebo cream in preventing palmar-plantar erythrodysesthesia in patients receiving doxorubicin hydrochloride liposome for metastatic breast cancer.
Drug: antiperspirant cream F511
Drug: pegylated liposomal doxorubicin hydrochloride
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
|Official Title:||Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial|
- Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2 [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]
- Patient-reported outcome [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]
- Adverse skin reaction to local therapy [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: Yes ]
- Extent of symptom relief [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]
- Recurrence of PPE grade ≥ 2 [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||June 2012|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Drug: antiperspirant cream F511
- 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.
|Aarau, Switzerland, CH-5001|
|Baden, Switzerland, CH-5404|
|Basel, Switzerland, CH-4031|
|Biel, Switzerland, CH-2501|
|Bulach, Switzerland, CH-8180|
|Chur, Switzerland, CH-7000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Luzerne, Switzerland, CH-6000|
|Olten, Switzerland, CH-4600|
|Schaffhausen, Switzerland, CH-8200|
|Institut Central des Hopitaux Valaisans|
|Sion, Switzerland, CH-1951|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Winterthur, Switzerland, CH-8400|
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Thomas Ruhstaller, MD||Cantonal Hospital of St. Gallen|