Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00736333
First received: July 25, 2008
Last updated: June 13, 2011
Last verified: June 2011
History of Changes
  Purpose

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 Intervention
Breast Neoplasm
 Drug: Pegylated Liposomal Doxorubicin

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observational Program of Caelyx in MBC - Prevention and Treatment of PPE and Infusion Reactions

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • Number of Participants With Infusion Reactions (IR) [ Time Frame: Day 1 up to Week 24 ] [ Designated as safety issue: Yes ]
    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.

  • Percent of Participants Taking Premedication for Prevention of IR [ Time Frame: Day 1, immediately prior to receiving first dose of pegylated liposomal doxorubicin ] [ Designated as safety issue: Yes ]
    Premedications for prevention of IR included corticosteroids, serotonin-3 receptor antagonists (anti-emetics), histamine-1 receptor blockers, and histamine-2 receptor blockers.

  • Number of Participants With Pre-existing Allergic Conditions Who Experienced an IR [ Time Frame: Cycles 1 & 3 (Week 4 & Week 12) ] [ Designated as safety issue: Yes ]
    Allergic conditions included food allergies, drug allergies, allergic rhinitis, histamine allergy, neurodermatitis, and chronic idiopathic urticaria.

  • Number of Occurrences of Palmar-plantar Erythrodysesthesia (PPE) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: Yes ]
    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.

  • Number of Times Premedications Were Given for Prevention of PPE [ Time Frame: Day 1 up to 24 weeks ] [ Designated as safety issue: Yes ]
    Pre-medications given included oral dexamethasone, vitamin B6, and other not clearly defined medications.


Secondary Outcome Measures:
  • Number of Participants With Complete Response (CR) or Partial Response (PR) [ Time Frame: Day 1 up to 24 weeks ] [ Designated as safety issue: No ]
    CR and PR were documented according to the clinical standards of each site.


Enrollment: 167
Study Start Date: November 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

Patients selected by investigator according to clinical routine

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with metastatic breast cancer

Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00736333     History of Changes
Other Study ID Numbers: P04878
Study First Received: July 25, 2008
Results First Received: June 13, 2011
Last Updated: June 13, 2011
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
 Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013