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Weekly and Every 3 Week Administration of Paclitaxel Liposome Injection in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02142790
Recruitment Status : Unknown
Verified July 2014 by Nanjing Luye Sike Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : May 20, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Nanjing Luye Sike Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
This is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: paclitaxel liposome injection Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2014
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: paclitaxel liposome injection weekly
paclitaxel liposome injection 100mg/m2 administered by intravenous on day1 and day8 of a 21-day cycle for at least 4cycles or till progression or intolerable
 Drug: paclitaxel liposome injection
Other Name: LIPUSU
Experimental: paclitaxel liposome injection every 3 weeks
paclitaxel liposome injection 175mg/m2 administered by intravenous on day1 of a 21-day cycle for at least 4cycles or till progression or intolerable
 Drug: paclitaxel liposome injection
Other Name: LIPUSU


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 24 months ]
  2. Clinical Benefit Rate [ Time Frame: 24 months ]
  3. Adverse Events [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or Male >18 years of age and < 70years of age, If female of childbearing potential, pregnancy test is negative before first dose of study drug and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
  • Stage IV disease
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Suitable for the treatment with paclitaxel as single agent regimen (first line or prior first line chemotherapy including adriamycin is allowed, If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen and if Her2+ patient, Herceptin therapy will be allowed.
  • Patient has the following values at Baseline: Absolute neutrophil count ≥ 1.5 x 10^9cells/L; platelets ≥ 100 x 10^9 cells/L; hemoglobin ≥ 10 g/dL. Aspartate transaminase (AST or SGOT), alanine aminotransferase (ALT or SGPT) ≤ 2.5x upper limit of normal range (ULN); total bilirubin ≤ 1.5ULN; creatinine ≤ 1.5 mg/dL.
  • Informed consent has been obtained.

Exclusion Criteria:

  • Parenchymal brain metastases.
  • History of other malignancy within the last 3 years
  • New York Heart Association (NYHA) Grade 2 or greater congestive heart failure,history of myocardial infarction or unstable angina or new occured angina within 6 months prior to study enrollment.
  • Concurrent other anticancer therapy.
  • History of serious organic disorders (including active infection or Cardiovascular disease), serious hepatic disease, serious blood coagulation diseases, cachexia
  • Sensory neuropathy of > Grade 1 at baseline.
  • Patients with prior hypersensitivity to paclitaxel
  • Pregnant or nursing women
  • enrolled in a different clinical study
  • No psychiatric illness and other situations that would limit compliance of study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142790


Contacts
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Contact: Quchang Ouyang, MD oyqc1969@126.com

Locations
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China, Hunan
Hunan Cancer Hospital Recruiting
Changsha, Hunan, China
Contact: Quchang Ouyang, MD       oyqc1969@126.com   
Sponsors and Collaborators
Nanjing Luye Sike Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Nanjing Luye Sike Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02142790    
Other Study ID Numbers: LY-TM-LPS-2014-02
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: July 22, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action