A Clinical Trial of Paclitaxel Loaded Polymeric Micelle in Patients With Taxane-Pretreated Recurrent Breast Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Korean Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00912639
First received: May 31, 2009
Last updated: June 15, 2009
Last verified: June 2009
  Purpose

The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).


Condition Intervention Phase
Recurrent Breast Cancer
Drug: Paclitaxel loaded Polymeric micelle
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Trial of Paclitaxel Loaded Polymeric Micelle (Genexol-PM®) in Patients With Taxane-Pretreated Recurrent Breast Cancer

Resource links provided by NLM:


Further study details as provided by Korean Breast Cancer Study Group:

Primary Outcome Measures:
  • Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Progression Free Survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Tumor control rate [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: May 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genexol-PM

All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion)

  1. Spiral CT : lesion ≥ 10mm (unidimension)
  2. X-ray, MRI, ultrasound : lesion ≥ 20 mm (unidimension)
Drug: Paclitaxel loaded Polymeric micelle
Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended.
Other Name: Genexol-PM®

Detailed Description:

Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged >=18 years
  2. WHO (ECOG) performance status 0-2
  3. Estimated life expectancy of >=3 months
  4. Have given written informed consent and are available for prolonged follow-up

Exclusion Criteria:

  1. Patients with previous chemotherapy for recurrent breast cancer
  2. Breast cancer recurrence within 12 months after taxane treatment
  3. Her-2/neu expression
  4. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin.
  5. Brain metastasis
  6. uncontrolled infection, medically uncontrollable heart disease
  7. other serious medical illness or prior malignancies
  8. Pregnant or lactating women were excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00912639

Locations
Korea, Republic of
Department of surgery, The Catholoic university of Korea, St. Mary's hospital.
Seoul, Korea, Republic of
Sponsors and Collaborators
Korean Breast Cancer Study Group
Investigators
Principal Investigator: Byung-Joo Song, MD.PhD. The Catholoic university of Korea, St. Mary's hospital.
  More Information

No publications provided

Responsible Party: Byung-Joo Song, The Catholoic university of Korea, St. Mary's hospital.
ClinicalTrials.gov Identifier: NCT00912639     History of Changes
Other Study ID Numbers: KBCSG004
Study First Received: May 31, 2009
Last Updated: June 15, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Korean Breast Cancer Study Group:
recurrent breast cancer
Genexol-PM

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014