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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00992706
First received: October 8, 2009
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Palmar-plantar Erythrodysesthesia
Drug: antiperspirant cream F511
Drug: pegylated liposomal doxorubicin hydrochloride
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Swiss Group for Clinical Cancer Research:

Primary Outcome Measures:
  • Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2 [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 91
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992706

Locations
Switzerland
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
Kantonsspital Baden
Baden, Switzerland, CH-5404
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
Spitalzentrum Biel
Biel, Switzerland, CH-2501
Spital Buelach
Bulach, Switzerland, CH-8180
Kantonsspital Graubuenden
Chur, Switzerland, CH-7000
Hopital Cantonal Universitaire de Geneve
Geneva, Switzerland, CH-1211
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital Luzern
Luzerne, Switzerland, CH-6000
Kantonsspital Olten
Olten, Switzerland, CH-4600
Onkologie Schaffhausen
Schaffhausen, Switzerland, CH-8200
Institut Central des Hopitaux Valaisans
Sion, Switzerland, CH-1951
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Kantonsspital Winterthur
Winterthur, Switzerland, CH-8400
UniversitaetsSpital Zuerich
Zurich, Switzerland, CH-8091
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Principal Investigator: Thomas Ruhstaller, MD Cantonal Hospital of St. Gallen
  More Information

No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00992706     History of Changes
Other Study ID Numbers: SAKK 92/08, SWS-SAKK-92/08, EU-20978, CDR0000652808
Study First Received: October 8, 2009
Last Updated: June 20, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
palmar-plantar erythrodysesthesia
stage IV breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Hand-Foot Syndrome
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Drug Eruptions
Dermatitis
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014