F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Local Antiperspirant for Prevention of Palmar-Plantar Erythrodysesthesia (PPE) in Patients Treated With Pegylated Liposomal Doxorubicin: A Randomized, Multicenter, Double Blinded, Phase III Trial

Conditions
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Breast Cancer, Palmar-plantar Erythrodysesthesia

Intervention / Treatment
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* Drug: antiperspirant cream F511
* Drug: pegylated liposomal doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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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®

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: antiperspirant cream F511|Placebo and verum cream once daily, in the morning, during the first week of the first PLD treatment only, then once daily, three times per week (in the morning). Tube R for right hand and foot, tube L for left hand and foot.|
|Drug: pegylated liposomal doxorubicin hydrochloride|According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2 |  | Until PPE grade ≥2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported outcome |  | Until PPE grade ≥2 | 
| Adverse skin reaction to local therapy |  | Until PPE grade ≥2 | 
| Extent of symptom relief |  | Until PPE grade ≥2 | 
| Recurrence of PPE grade ≥ 2 |  | Until PPE grade ≥2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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palmar-plantar erythrodysesthesia, stage IV breast cancer, male breast cancer