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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00736333
Recruitment Status : Completed
First Posted : August 15, 2008
Results First Posted : July 7, 2011
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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).

Condition or disease Intervention/treatment
Breast Neoplasm Drug: Pegylated Liposomal Doxorubicin

Detailed Description:
Patients selected by investigator according to clinical routine

Study Type : Observational
Actual Enrollment : 167 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions
Study Start Date : November 2006
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort Intervention/treatment
Pegylated Liposomal Doxorubicin
Subjects with metastatic breast cancer
Drug: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin (Caelyx) 50 mg/m^2, given for up to 6 cycles
Other Name: SCH 200746

Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic breast cancer

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00736333     History of Changes
Other Study ID Numbers: P04878
First Posted: August 15, 2008    Key Record Dates
Results First Posted: July 7, 2011
Last Update Posted: November 5, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action