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

May 14, 2019 updated by: Swiss Group for Clinical Cancer Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Switzerland
- - Aarau, Switzerland, CH-5001
    - Kantonsspital Aarau
  - Baden, Switzerland, CH-5404
    - Kantonsspital Baden
  - Basel, Switzerland, CH-4031
    - Universitaetsspital-Basel
  - Biel, Switzerland, CH-2501
    - Spitalzentrum Biel
  - Bulach, Switzerland, CH-8180
    - Spital Buelach
  - Chur, Switzerland, CH-7000
    - Kantonsspital Graubuenden
  - Geneva, Switzerland, CH-1211
    - Hôpital Cantonal Universitaire de Genève
  - Lausanne, Switzerland, CH-1011
    - Centre hospitalier universitaire vaudois
  - Luzerne, Switzerland, CH-6000
    - Kantonsspital Luzern
  - Olten, Switzerland, CH-4600
    - Kantonsspital Olten
  - Schaffhausen, Switzerland, CH-8200
    - Onkologie Schaffhausen
  - Sion, Switzerland, CH-1951
    - Institut Central des Hopitaux Valaisans
  - St. Gallen, Switzerland, CH-9007
    - Kantonsspital - St. Gallen
  - Winterthur, Switzerland, CH-8400
    - Kantonsspital Winterthur
  - Zurich, Switzerland, CH-8091
    - Universitaetsspital Zuerich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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®

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Group for Clinical Cancer Research

Investigators

Principal Investigator: Thomas Ruhstaller, MD, Cantonal Hospital of St. Gallen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria