A Randomized, Open-Label Trial Comparing Treatment With Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer (PELICAN Trial)

Merck Sharp & Dohme LLC0 sites210 target enrollmentJanuary 13, 2006

ConditionsBreast Cancer

InterventionsPegylated liposomal doxorubicin (SCH 200746)Capecitabine

DrugsPegylated liposomal doxorubicin (SCH 200746)Capecitabine

Overview

Phase: Phase 3
Intervention: Pegylated liposomal doxorubicin (SCH 200746)
Conditions: Breast Cancer
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 210
Primary Endpoint: Time to Disease Progression (TTP) Using Response Evaluation Criteria in Solid Tumors (RECIST)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 13, 2006

End Date

October 18, 2010

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients must be female.
•Patients must have metastatic disease of a cytological or histological confirmed breast cancer.
•Patients must be 18 years or older.
•Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated), however, patients who only have non-measurable/evaluable disease are not excluded. Also patients with only bone metastasis are not excluded.
•Patients must have an Eastern Cooperative Oncology Group (ECOG) 0-
•Patients must have a sufficient life expectancy to be treated with chemotherapy.
•Patients must be willing and able to complete study questionnaires.
•Patients must have adequate renal function as evidenced by serum creatinine \<=1.5 mg/dL, or a creatinine clearance of \>=45 mL/min (if serum creatinine is \> 1.5 mg/dL but \<= 1.8 mg/dL).
•Patients must have adequate bone marrow function as evidenced by leukocyte count greater than 3.5 g/L, hemoglobin \>=9.0 g/dL, and platelet count \>=100x10\^9/L.
•Patients must have adequate liver function as evidenced by bilirubin of \<=1.5 times the upper limits of normal (ULN) and alkaline phosphatase \<=3 times, ULN unless related to liver metastasis.

Exclusion Criteria

•History of receiving prior chemotherapy in the metastatic setting (Note: patients may have had
•hormonal therapy or chemotherapy in the adjuvant setting; patients may have received hormonal therapy in metastatic setting, patients may have received local radiotherapy).
•Patients with positive estrogen- / progesterone-receptor status, where an endocrine therapy is indicated. However, patients progressing under hormonal therapy are not excluded.
•Patients with known hypersensitivity to doxorubicinhydrochlorid or to any of the excipients OR known hypersensitivity to capecitabine or fluorouracil or to any of the excipients.
•Patients with known DPD (dihydro pyrimidine dehydrogenase) deficiency.
•Patients who are receiving a concomitant treatment with sorivudine or its chemically related analogues, such as brivudine.
•Patients who are taking concomitant medications (except bisphosphonates) for metastatic disease, including hormonal therapy, radiation therapy, trastuzumab, or biologicals are also not permitted.
•Patients with Human epidermal growth factor receptor 2 (Her-2/neu) overexpressing tumors with the most recent evaluation as the relevant result
•immunologically Her2neu 3+ positive
•Her2neu-2+ positive and ´Fluorescent in-situ hybridization (FISH)´ positive

Arms & Interventions

Pegylated liposomal doxorubicin

Intervention: Pegylated liposomal doxorubicin (SCH 200746)

Capecitabine

Intervention: Capecitabine

Outcomes

Primary Outcomes

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 Outcomes

Number of Participants With an Overall Response (Complete Response [CR] + Partial Response [PR]) Between PLD and Capecitabine Treatment Groups(From Day 1 (Cycle 1) until First Evidence/Diagnosis of Progressive Disease or Death)
Overall Survival Time in the PLD and Capecitabine Treatment Groups(From Day 1 (Cycle 1) until Death)
Time to Treatment Failure in the PLD and the Capecitabine Treatment Groups(From Day 1 (Cycle 1) until End of Treatment)
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))(From Screening to Day 1 of every Treatment Cycle up to 12 Cycles)