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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Doxorubicin; Liposomal doxorubicin

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®