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Completed

NCT Number: NCT00736333

A Study to Evaluate Safety and Tolerability in Patients With Metastatic Breast Cancer Receiving Treatment With Caelyx (Study P04878)(COMPLETED)

This is a study to evaluate the safety and tolerability of Caelyx used for the treatment of metastatic breast cancer (MBC), focusing on infusion reaction and palmar-plantar erythrodysesthesia (PPE).

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

Patients selected by investigator according to clinical routine

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with metastatic breast cancer

Exclusion criteria

  • History of hypersensitivity to Caelyx or its components
  • Women who are pregnant or breast-feeding
  • Patients with severe myelosuppression

Treatment and study plan

Pegylated liposomal doxorubicin

Drug

Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles

Other names: SCH 200746

Primary outcomes

  1. Number of Participants With Infusion Reactions (IR)

    Time frame: Day 1 up to Week 24

    Infusion reaction was defined as an allergic reaction or anaphylactoid reaction characterized by shortness of breath, hypotension, back pain, chest pain, chills, flush, sweating, fever, nausea, dizziness, rash, pruritis, or tachycardia.

  2. Percent of Participants Taking Premedication for Prevention of IR

    Time frame: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin

    Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.

  3. Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR

    Time frame: Cycles 1 & 3 (Week 4 & Week 12)

    Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.

  4. Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE)

    Time frame: Up to 24 weeks

    PPE was defined as a dermatological adverse event characterized by swelling, pain, edema, erythema, desquamation, that may have ultimately resulted in fissuring and ulceration, involving fingers, toes, palms, plantar aspects of the feet, and other pressure-sensitive areas of the skin.

  5. Number of Times Premedications Were Given for Prevention of PPE

    Time frame: Day 1 up to 24 weeks

    Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.

Secondary outcomes

  1. Number of Participants With Complete Response (CR) or Partial Response (PR)

    Time frame: Day 1 up to 24 weeks

    CR and PR were documented according to the clinical standards of each site.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 15, 2008
Registry last updated
Nov 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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