Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059 AM2) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00604968

Purpose

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.

Condition	Intervention	Phase
Breast Neoplasms	Drug: Caelyx (pegylated liposomal doxorubicin; SCH 200746)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Caelyx(R) in Breast Cancer in the Elderly. Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet

U.S. FDA Resources

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Time to treatment failure. Treatment failure is defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. [ Time Frame: Until progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Safety, response rate, time to progression, survival, symptom control measured by patient assessment, quality of life, and analysis of treatment predictive factors in tumor tissue and angiogenetic factors, proteomics and snp-analysis in serum/plasma. [ Time Frame: Time to response, duration of response, time to progression and survival will be calculated. The proportion of patients having QoL at 3 months unchanged or better than at the time of inclusion will be calculated. ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	February 2007
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Caelyx: Experimental	Drug: 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).

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.
- WHO Performance Status 0 - 2
- Measurable disease in accordance with 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;
  - 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.
- HER-2 positivity eligible for treatment with trastuzumab, or 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05059
Study First Received:	January 21, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00604968 History of Changes
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Anti-Bacterial Agents
Skin Diseases
Breast Neoplasms
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009