F511 Cream in Preventing Palmar-Plantar Erythrodysesthesia in Patients Receiving Doxorubicin Hydrochloride Liposome for Metastatic Breast Cancer
This study has been completed.
Sponsor:
Swiss Group for Clinical Cancer Research
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
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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:
Detailed Description:
-
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.
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
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 | Kantonsspital 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Doxorubicin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013