Clinical trial NCT00992706: F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Palmar-plantar Erythrodysesthesia
Keywords: palmar-plantar erythrodysesthesia
stage IV breast cancer
male breast cancer
Lead sponsor: Swiss Group for Clinical Cancer Research
Sponsor class: OTHER
First posted: 2009-10-09
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility 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®

Primary outcomes:
measure: Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2
timeFrame: Until PPE grade ≥2
Secondary outcomes:
measure: Patient-reported outcome
timeFrame: Until PPE grade ≥2
measure: Adverse skin reaction to local therapy
timeFrame: Until PPE grade ≥2
measure: Extent of symptom relief
timeFrame: Until PPE grade ≥2
measure: Recurrence of PPE grade ≥ 2
timeFrame: Until PPE grade ≥2
Other outcomes:
Locations:
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau
city: Baden
country: Switzerland
facility: Kantonsspital Baden
city: Basel
country: Switzerland
facility: Universitaetsspital-Basel
city: Biel
country: Switzerland
facility: Spitalzentrum Biel
city: Bulach
country: Switzerland
facility: Spital Buelach
city: Chur
country: Switzerland
facility: Kantonsspital Graubuenden
city: Geneva
country: Switzerland
facility: Hopital Cantonal Universitaire de Geneve
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Luzerne
country: Switzerland
facility: Kantonsspital Luzern
city: Olten
country: Switzerland
facility: Kantonsspital Olten
city: Schaffhausen
country: Switzerland
facility: Onkologie Schaffhausen
city: Sion
country: Switzerland
facility: Institut Central des Hopitaux Valaisans
city: St. Gallen
country: Switzerland
facility: Kantonsspital - St. Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zuerich
Study officials:
affiliation: Cantonal Hospital of St. Gallen
name: Thomas Ruhstaller, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Templeton AJ, Ribi K, Surber C, Sun H, Hsu Schmitz SF, Beyeler M, Dietrich D, Borner M, Winkler A, Muller A, von Rohr L, Winterhalder RC, Rochlitz C, von Moos R, Zaman K, Thurlimann BJ, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK) Coordinating Center. Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08). Breast. 2014 Jun;23(3):244-9. doi: 10.1016/j.breast.2014.02.005. Epub 2014 Mar 20.