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

Primary Purpose

Breast Cancer, Palmar-plantar Erythrodysesthesia

Status
Completed
Phase
Phase 3
Locations
Switzerland
Study Type
Interventional
Intervention
antiperspirant cream F511
pegylated liposomal doxorubicin hydrochloride
Sponsored by
Swiss Group for Clinical Cancer Research
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring palmar-plantar erythrodysesthesia, stage IV breast cancer, male breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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®

Sites / Locations

  • Kantonsspital Aarau
  • Kantonsspital Baden
  • Universitaetsspital-Basel
  • Spitalzentrum Biel
  • Spital Buelach
  • Kantonsspital Graubuenden
  • Hopital Cantonal Universitaire de Geneve
  • Centre Hospitalier Universitaire Vaudois
  • Kantonsspital Luzern
  • Kantonsspital Olten
  • Onkologie Schaffhausen
  • Institut Central des Hopitaux Valaisans
  • Kantonsspital - St. Gallen
  • Kantonsspital Winterthur
  • UniversitaetsSpital Zuerich

Outcomes

Primary Outcome Measures

Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2

Secondary Outcome Measures

Patient-reported outcome
Adverse skin reaction to local therapy
Extent of symptom relief
Recurrence of PPE grade ≥ 2

Full Information

First Posted
October 8, 2009
Last Updated
May 14, 2019
Sponsor
Swiss Group for Clinical Cancer Research
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1. Study Identification

Unique Protocol Identification Number
NCT00992706
Brief Title
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

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swiss Group for Clinical Cancer Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Palmar-plantar Erythrodysesthesia
Keywords
palmar-plantar erythrodysesthesia, stage IV breast cancer, male breast cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
antiperspirant cream F511
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
pegylated liposomal doxorubicin hydrochloride
Intervention Description
According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.
Primary Outcome Measure Information:
Title
Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2
Time Frame
Until PPE grade ≥2
Secondary Outcome Measure Information:
Title
Patient-reported outcome
Time Frame
Until PPE grade ≥2
Title
Adverse skin reaction to local therapy
Time Frame
Until PPE grade ≥2
Title
Extent of symptom relief
Time Frame
Until PPE grade ≥2
Title
Recurrence of PPE grade ≥ 2
Time Frame
Until PPE grade ≥2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Ruhstaller, MD
Organizational Affiliation
Cantonal Hospital of St. Gallen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
CH-5001
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
CH-5404
Country
Switzerland
Facility Name
Universitaetsspital-Basel
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Spitalzentrum Biel
City
Biel
ZIP/Postal Code
CH-2501
Country
Switzerland
Facility Name
Spital Buelach
City
Bulach
ZIP/Postal Code
CH-8180
Country
Switzerland
Facility Name
Kantonsspital Graubuenden
City
Chur
ZIP/Postal Code
CH-7000
Country
Switzerland
Facility Name
Hopital Cantonal Universitaire de Geneve
City
Geneva
ZIP/Postal Code
CH-1211
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
ZIP/Postal Code
CH-1011
Country
Switzerland
Facility Name
Kantonsspital Luzern
City
Luzerne
ZIP/Postal Code
CH-6000
Country
Switzerland
Facility Name
Kantonsspital Olten
City
Olten
ZIP/Postal Code
CH-4600
Country
Switzerland
Facility Name
Onkologie Schaffhausen
City
Schaffhausen
ZIP/Postal Code
CH-8200
Country
Switzerland
Facility Name
Institut Central des Hopitaux Valaisans
City
Sion
ZIP/Postal Code
CH-1951
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
CH-8400
Country
Switzerland
Facility Name
UniversitaetsSpital Zuerich
City
Zurich
ZIP/Postal Code
CH-8091
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24656636
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.
Results Reference
result

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

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