Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059)

NCT ID: NCT00604968

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-07
• Study Completion Date: 2009-10-16

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for metastatic or locally advanced breast cancer, not amenable to surgery.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Caelyx

Group Type: EXPERIMENTAL

Caelyx (pegylated liposomal doxorubicin; SCH 200746)

Intervention Type: DRUG

Caelyx will be administered intravenously at a dose of 40 mg/m\^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses \>=90 mg).

Interventions

Caelyx (pegylated liposomal doxorubicin; SCH 200746)

Caelyx will be administered intravenously at a dose of 40 mg/m\^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses \>=90 mg).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients meeting the following criteria will be eligible for enrollment.

• Female patients with histologic or cytologic diagnosis of breast cancer that is locally advanced or metastatic, and not amenable to surgery.
• Age >= 65 years.
• World Health Organization (WHO) Performance Status 0 - 2
• Measurable disease in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Patients with bone metastasis can also be included but will be evaluated according to WHO criteria. Patients with non-measurable disease can also be included.
• Left ventricular ejection fraction (LVEF) >= 50% verified by ultrasound cardiography (UCG); no clinical signs of heart disease.
• Normal organ function, except due to disease involvement, however maximum deviation:

• S-creatinine <= 1.5 x upper normal limit;
• Bilirubin <= 2 x upper normal limit;
• Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) <= 3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT <= 5 x upper normal limit.
• Adequate bone marrow function, ie:

• Platelets >= 100 x 10^9/L;
• Neutrophils >= 1.5 x 10^9/L;
• White Blood Cell (WBC) >= 3.0 x 10^9/L;
• Hemoglobin > 90 g/L.
• Life expectancy >= 12 weeks.
• Patients having received oral and written information and having provided written informed consent.

Exclusion Criteria

• Patients will not be enrolled if any of the following conditions apply.

• Previous chemotherapy for metastatic disease. (The patient may have received previous endocrine therapy or single-drug Herceptin. Intrapleural or intrapericardial Novantrone is allowed.)
• Recurrence <= 12 months after adjuvant anthracycline-containing treatment and/or prior doxorubicin > 300 mg/m^2 or epirubicin > 540 mg/m^2.
• Myocardial infarction within 6 months of planned inclusion.
• Symptomatic brain metastases.
• Human Epidermal growth factor Receptor 2 (HER-2) positivity eligible for treatment with trastuzumab, or estrogen receptor (ER) positivity eligible for hormonal therapy.
• Allergy to anthracyclines.
• Uncontrolled infection.
• Other not radically treated malignancy.
• Other disease or condition contraindicating treatment or not allowing follow-up.

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Green H, Stal O, Bachmeier K, Backlund LM, Carlsson L, Hansen J, Lagerlund M, Norberg B, Franzen A, Aleskog A, Malmstrom A. Pegylated liposomal doxorubicin as first-line monotherapy in elderly women with locally advanced or metastatic breast cancer: novel treatment predictive factors identified. Cancer Lett. 2011 Dec 27;313(2):145-53. doi: 10.1016/j.canlet.2011.07.017. Epub 2011 Aug 31.

Reference Type: RESULT

PMID: 22056077 (View on PubMed)

Other Identifiers

P05059

Identifier Type: -

Identifier Source: org_study_id