Status:
COMPLETED
F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
Lead Sponsor:
Swiss Cancer Institute
Conditions:
Breast Cancer
Palmar-plantar Erythrodysesthesia
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
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 tr...
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 hy...
Eligibility Criteria
Inclusion
- 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®
Exclusion
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00992706
Start Date
September 1 2009
End Date
June 1 2012
Last Update
May 15 2019
Active Locations (15)
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1
Kantonsspital Aarau
Aarau, Switzerland, CH-5001
2
Kantonsspital Baden
Baden, Switzerland, CH-5404
3
Universitaetsspital-Basel
Basel, Switzerland, CH-4031
4
Spitalzentrum Biel
Biel, Switzerland, CH-2501