The Efficacy and Safety of Pegylated Liposomal Doxorubicin Compared With Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (P04445/MK-2746-071)
|ClinicalTrials.gov Identifier: NCT00266799|
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : November 16, 2011
Last Update Posted : June 8, 2017
Merck Sharp & Dohme Corp.
Essex Pharma GmbH
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
This is an open-label, multinational, randomized, multicenter trial designed to compare pegylated liposomal doxorubicin with capecitabine as first line chemotherapy of metastatic breast cancer. The primary objective of the study is to compare the time to disease progression, although overall response rates, overall survival, quality of life, time to treatment failure, and safety and tolerability will also be assessed.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Pegylated liposomal doxorubicin (SCH 200746) Drug: Capecitabine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (PELICAN Trial)|
|Actual Study Start Date :||January 13, 2006|
|Primary Completion Date :||September 29, 2010|
|Study Completion Date :||October 18, 2010|
|Experimental: Pegylated liposomal doxorubicin||
Drug: Pegylated liposomal doxorubicin (SCH 200746)
pegylated liposomal doxorubicin (50 mg/m^2 q 28 days) was administered intravenously until disease progression or unacceptable toxicity
|Active Comparator: Capecitabine||
capecitabine (1250 mg/m^2 BID x 14 days q 21 days) in tablets of 150 mg and 500 mg was administered orally, until disease progression or unacceptable toxicity
Primary Outcome Measures :
- Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death ]TTP was defined as the time from onset of treatment with study drug until first evidence/diagnosis of progressive disease or - in the absence of any diagnosis of progressive disease - until the participant´s death. Diagnosis of progressive disease was done according to RECIST (Version 1.0) and/or investigator assessment based on RECIST. RECIST criteria used changes in the largest diameter of target/non-target lesions. Target (measurable) lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions.
Secondary Outcome Measures :
- Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups [ Time Frame: From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death ]Overall responses by investigator assessment/RECIST criteria of participant responses; CR=disappearance of target/nontarget lesions + PR=30% decrease in longest diameter sum (noting baseline sum) of target lesions. RECIST used changes in the largest diameter of target/non-target lesions. Target lesions were up to a maximum of 5 per organ & >20 mm by clinical imaging (>=10 mm with spiral CT scan). Non-target lesions were all other lesions. Evaluation of progress was repeated every 3 months (+/-7 days) post first date of lesion measurements, in detection absence until the participant´s death.
- Overall Survival Time in the PLD and Capecitabine Treatment Groups [ Time Frame: From Day 1 (Cycle 1) until Death ]Survival time was defined as duration time from onset of treatment with the study drug until death.
- Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups [ Time Frame: From Day 1 (Cycle 1) until End of Treatment ]Time to treatment failure was defined as the duration of time from the date of the first administration of the study drug to the date of discontinuation of the study drug for any reason.
- Quality of Life (QoL) Measured by QoL Questionnaire (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) + Subjective Significance Questionnaire (SSQ)) [ Time Frame: From Screening to Day 1 of every Treatment Cycle up to 12 Cycles ]QoL questionnaire was an EORTC QLQ-C30 & SSQ integration. Scores on the SSQ scale ranged from 1 (very much worse) - 7 (very much better). SSQ consisted of 4 items which corresponded to core domains in the 30 Item EORTC QLQ-C30, such as improvement/deterioration in physical functioning, emotional functioning, social functioning, global QoL. Percentages were based on number of participants at each cycle & rounded to the nearest whole number. Early Withdrawal Questionnaires were obtained in 7-14 days of study drug final dose.
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