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

NCT00779285 | Terminated Phase 4 Results

• 2 other identifiers: P04057EUDRACT NO. 2004-001177-25
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Neoplasm

Outcome Measures

Primary Outcomes (1)

• Cardiac Events

  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).

  Every 4 weeks during 6 cycles.

Study Arms (1)

Single-arm

EXPERIMENTAL

Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles

Drug: Pegylated Liposomal Doxorubicin

Interventions

Pegylated Liposomal Doxorubicin DRUG

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.

Also known as: SCH 200746

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: February 1, 2006
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: July 14, 2015
• Results First Posted: March 10, 2010

Record last verified: 2015-06