F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydr… (NCT00992706) | Clinical Trial Compass
CompletedPhase 3
F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
Switzerland91 participantsStarted 2009-09
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
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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®