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

October 8, 2009
June 20, 2012
September 2009
August 2011   (final data collection date for primary outcome measure)
Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2 [ Time Frame: Until PPE grade ≥2 ] [ Designated as safety issue: No ]
Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2 [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00992706 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Patient-reported outcome [ Designated as safety issue: No ]
  • Adverse skin reaction to local therapy [ Designated as safety issue: Yes ]
  • Extent of symptom relief [ Designated as safety issue: No ]
  • Recurrence of PPE grade ≥ 2 [ Designated as safety issue: No ]
Not Provided
Not Provided
 
F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
  • Breast Cancer
  • Palmar-plantar Erythrodysesthesia
  • 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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
June 2012
August 2011   (final data collection date for primary outcome measure)

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®
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00992706
SAKK 92/08, SWS-SAKK-92/08, EU-20978, CDR0000652808
No
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Principal Investigator: Thomas Ruhstaller, MD Cantonal Hospital of St. Gallen
Swiss Group for Clinical Cancer Research
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP