Safety Study of CAELYX in Patients With Metastatic Breast Cancer Previously Treated With Anthracyclines (Study P04057)(TERMINATED)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00779285
First received: October 23, 2008
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.


Condition Intervention Phase
Breast Neoplasm
Drug: Pegylated Liposomal Doxorubicin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cardiac Safety Profile of Caelyx Therapy in Anthracyclin Pretreated Metastatic Breast Cancer Patients.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Cardiac Events [ Time Frame: Every 4 weeks during 6 cycles. ] [ Designated as safety issue: Yes ]
    A cardiac event was defined as a decrease in left ventricular ejection fraction (LVEF) of >=20 points from baseline if the resting LVEF remained in the normal range, or a decrease of >=10 points if the LVEF became abnormal (lower than the institutional lower limit of normal).


Enrollment: 1
Study Start Date: February 2006
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-arm
Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
Drug: Pegylated Liposomal Doxorubicin
Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.
Other Name: SCH 200746

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with histologically or cytologically confirmed metastatic breast cancer (no prior chemotherapy for metastatic disease).
  • Prior treatment with an anthracyclin-containing regimen in the adjuvant setting (cumulative dose >240mg/m^2 and <360mg/m^2 doxorubicin or >430mg/m^2 and <650mg/m^2 epirubicin).
  • Women >18 years of age.
  • Documented measurable and/or evaluable metastatic breast cancer by appropriate radiological imaging (computed tomography (CT) scan and/or magnetic resonance imaging (MRI)).
  • Performance status of at least 60% (Karnofsky index) and a life expectancy of at least 12 weeks.
  • Left ventricular ejection fraction >50%.
  • Normal organ function, except if abnormal due to tumor involvement.

    • Adequate bone marrow function as indicated:

      • Platelets >100,000/mm^3
      • Hemoglobin >9 g/dL
      • Neutrophils >1,500/mm^3
    • Adequate renal function as indicated by:

      • Serum Creatinine <1.5 x the upper limit of normal
    • Adequate liver function, as indicated by:

      • Bilirubin and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2 times upper limit of normal (<4 times upper limit of normal when related to primary disease)
  • Subjects must be capable to demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
  • Women of childbearing potential (includes women who are less than 1 year postmenopausal and women who become sexually active) must be using an acceptable method of birth control (e.g., hormonal contraceptive, medically prescribed intrauterine device (IUD), condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
  • Subjects must understand and be able to adhere to the dosing and visit schedules.

Exclusion Criteria:

  • Patient is pregnant or is breastfeeding.
  • Patients with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
  • Hypersensitivity to anthracycline therapy or a history of severe hypersensitivity reactions to products containing Cremophor® EL (e.g., cyclosporin for injection concentrate and teniposide for injection concentrate).
  • Prior chemotherapy for metastatic disease.
  • Clinically significant hepatic disease (except liver metastases of primary disease).
  • Uncontrolled bacterial, viral, or fungal infection.
  • Radiotherapy in the last 4 weeks or prior radiation therapy to more than one-third of the hemopoietic sites.
  • Any other currently known malignancy or pre-malignant lesions or any history of other malignancy within the past five years (except non-melanoma skin cancer and surgically cured cervical cancer).
  • Symptomatic brain metastasis.
  • Patients who are incapacitated, largely or wholly bedridden or confined to a wheelchair, and who have little or no ability for self-care.
  • Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurological or cerebral disease.
  • Documented human immunodeficiency virus (HIV) infection.
  • Any condition (medical, social, psychological) which would prevent adequate follow-up.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00779285     History of Changes
Other Study ID Numbers: P04057, EUDRACT NO. 2004-001177-25
Study First Received: October 23, 2008
Results First Received: February 11, 2010
Last Updated: May 5, 2014
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on October 20, 2014