Clinical trial NCT00604968: Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059)
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Breast Neoplasms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-01-30
Enrollment: 25
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).
timeFrame: Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Secondary outcomes:
measure: Number of Patients With Stable Disease (SD) as Best Response
timeFrame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
measure: Number of Patients With Partial Response (PR) as Best Response
timeFrame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
measure: Number of Patients With Progressive Disease (PD) as Best Response
timeFrame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
measure: Number of Patients Requiring Dose Reduction
timeFrame: Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).
measure: Time to Response
timeFrame: Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
measure: Duration of Response
timeFrame: Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
measure: Time to Progression
timeFrame: Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
measure: Duration of Overall Survival
timeFrame: Time of treatment until death, up to the time that all participants ended treatment
measure: Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment
timeFrame: Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).
Other outcomes:
Locations:
Study officials:
References:
citation: 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.