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

NCT00992706 | Completed Phase 3

• 4 other identifiers: SAKK 92/08SWS-SAKK-92/08EU-20978CDR0000652808
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 15

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.

Conditions

Breast Cancer; Palmar-plantar Erythrodysesthesia

Keywords

palmar-plantar erythrodysesthesia; stage IV breast cancer; male breast cancer

Outcome Measures

Primary Outcomes (1)

• Palmar-plantar erythrodysesthesia (PPE, hand-foot syndrome, HFS) grade ≥ 2

  Until PPE grade ≥2

Secondary Outcomes (4)

• Patient-reported outcome

  Until PPE grade ≥2

• Adverse skin reaction to local therapy

  Until PPE grade ≥2

• Extent of symptom relief

  Until PPE grade ≥2

• Recurrence of PPE grade ≥ 2

  Until PPE grade ≥2

Interventions

antiperspirant cream F511 DRUG

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.

pegylated liposomal doxorubicin hydrochloride DRUG

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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®

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (15)

Kantonsspital Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Spital Buelach

Bülach, CH-8180, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Luzern

Luzerne, CH-6000, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Onkologie Schaffhausen

Schaffhausen, CH-8200, Switzerland

Location

Institut Central des Hopitaux Valaisans

Sion, CH-1951, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 24656636 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Hand-Foot Syndrome; Breast Neoplasms, Male

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Drug Eruptions; Dermatitis; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Thomas Ruhstaller, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2009
• First Posted: October 9, 2009
• Study Start: September 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: June 1, 2012
• Last Updated: May 15, 2019

Record last verified: 2019-05

Locations

CH (15)