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

October 31, 2014 updated by: Merck Sharp & Dohme LLC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients selected by investigator according to clinical routine

Study Type

Observational

Enrollment (Actual)

167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with metastatic breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • SCH 200746

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 up to Week 24
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.
Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin
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.
Cycles 1 & 3 (Week 4 & Week 12)
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.
Up to 24 weeks
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.
Day 1 up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

July 25, 2008

First Submitted That Met QC Criteria

August 14, 2008

First Posted (Estimate)

August 15, 2008

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

October 31, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P04878

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasm

Clinical Trials on Pegylated Liposomal Doxorubicin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe