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

NCT ID: NCT00992706

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

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 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.

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 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.

Conditions

Breast Cancer; Palmar-plantar Erythrodysesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Interventions

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.

Intervention Type: DRUG

pegylated liposomal doxorubicin hydrochloride

According to local practice. 1, 2 and 4 week schedules with at least 10mg/m2 per week are allowed.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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®

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Ruhstaller, MD

Role: PRINCIPAL_INVESTIGATOR

Cantonal Hospital of St. Gallen

Locations

Kantonsspital Aarau

Aarau, , Switzerland

Kantonsspital Baden

Baden, , Switzerland

Universitaetsspital-Basel

Basel, , Switzerland

Spitalzentrum Biel

Biel, , Switzerland

Spital Buelach

Bülach, , Switzerland

Kantonsspital Graubuenden

Chur, , Switzerland

Hopital Cantonal Universitaire de Geneve

Geneva, , Switzerland

Centre Hospitalier Universitaire Vaudois

Lausanne, , Switzerland

Kantonsspital Luzern

Luzerne, , Switzerland

Kantonsspital Olten

Olten, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

Onkologie Schaffhausen

Schaffhausen, , Switzerland

Institut Central des Hopitaux Valaisans

Sion, , Switzerland

Kantonsspital Winterthur

Winterthur, , Switzerland

UniversitaetsSpital Zuerich

Zurich, , Switzerland

Countries

Switzerland

References

Templeton AJ, Ribi K, Surber C, Sun H, Hsu Schmitz SF, Beyeler M, Dietrich D, Borner M, Winkler A, Muller A, von Rohr L, Winterhalder RC, Rochlitz C, von Moos R, Zaman K, Thurlimann BJ, Ruhstaller T; Swiss Group for Clinical Cancer Research (SAKK) Coordinating Center. Prevention of palmar-plantar erythrodysesthesia with an antiperspirant in breast cancer patients treated with pegylated liposomal doxorubicin (SAKK 92/08). Breast. 2014 Jun;23(3):244-9. doi: 10.1016/j.breast.2014.02.005. Epub 2014 Mar 20.

Reference Type: RESULT

PMID: 24656636 (View on PubMed)

Other Identifiers

SWS-SAKK-92/08

Identifier Type: -

Identifier Source: secondary_id

EU-20978

Identifier Type: -

Identifier Source: secondary_id

CDR0000652808

Identifier Type: -

Identifier Source: secondary_id

SAKK 92/08

Identifier Type: -

Identifier Source: org_study_id