NCT00604968TerminatedPhase 4
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 25
- Primary Endpoint
- 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).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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^
- •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.
Arms & Interventions
Caelyx
Experimental
Intervention: Caelyx (pegylated liposomal doxorubicin; SCH 200746) (Drug)
Outcomes
Primary Outcomes
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).
Time Frame: 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).
Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: \>=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.
Secondary Outcomes
- Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment(Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).)
- Number of Patients With Stable Disease (SD) as Best Response(Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).)
- Number of Patients With Partial Response (PR) as Best Response(Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).)
- Number of Patients With Progressive Disease (PD) as Best Response(Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).)
- Number of Patients Requiring Dose Reduction(Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).)
- Time to Response(Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).)
- Duration of Response(Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).)
- Time to Progression(Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).)
- Duration of Overall Survival(Time of treatment until death, up to the time that all participants ended treatment)
Investigators
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