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Paclitaxel(Phyxol) and Cisplatin as First-Line Chemotherapy for Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by National Taiwan University Hospital, July 2005
First Received: September 8, 2005   Last Updated: July 29, 2007   History of Changes
Sponsored by: National Taiwan University Hospital
Information provided by: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00154882
  Purpose

The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen. The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival.


Condition Intervention Phase
Breast Cancer
Drug: Paclitaxel ( Phyxol ) , Cisplatin
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Weekly Low-Dose Paclitaxel(Phyxol) Plus 24-Hour Infusion of Cisplatin as First-Line Chemotherapy for Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The primary endpoint of this phase II trial is the objective response rate of the stage I (low-dose) regimen. [ Time Frame: 2003~2008 ]

Secondary Outcome Measures:
  • The secondary endpoints include treatment-related toxicity, the change in quality of life, progression free survival and overall survival. [ Time Frame: 2003~2008 ]

Estimated Enrollment: 43
Study Start Date: September 2003
Estimated Study Completion Date: July 2007
Arms Assigned Interventions
A: Experimental Drug: Paclitaxel ( Phyxol ) , Cisplatin

Detailed Description:

Breast cancer is one of the leading causes of cancer death for women in Taiwan. We have recently demonstrated that combination of paclitaxel and cisplatin, at conventional doses, is highly effective in the treatment of breast cancer. However, the acute and cumulative toxicities of paclitaxel have been troublesome to a significant portion of the patients. Several lines of evidence suggested that weekly paclitaxel, at a much lower dose range of 40 to 50 mg/m2 per week, may be as effective as that of the conventional doses of paclitaxel (80 to 90 mg/m2 per week) for patients with metastatic ovarian and lung cancers. The low-dose regimen of paclitaxel may significantly improve the compliance of the patients. This open-label phase II trial is designed to test this hypothesis.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Women with histologically proven breast cancer and clinical evidence of distant metastasis 2.The index lesions should be at least 20 mm × 20 mm in size. 3.Age must be older than 18 and younger than 75 year-old.4.Karnofsky performance status >70% 5.Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000, absolute neutrophil count (ANC)> 1,500, platelet>100,000 .6.Liver transaminases < 3 times upper normal limit if no liver metastasis and 5 times upper normal limit if liver metastasis is present; total bilirubin <2 mg/dl; serum creatinine< 1.5 mg/dl.7.No prior chemotherapy for metastatic disease. Previous chemotherapy as adjuvant treatment is acceptable, if the adjuvant chemotherapy has been completed at least 6 months before entry into in this study.8.If the patients have received hormonal therapy for metastatic disease, there must be definite evidence of disease progression under the hormonal therapy, and hormonal therapy should be discontinued before entry into this study.9. Previous or concurrent radiotherapy is acceptable if the area of radiation does not involve the site of the index tumor lesions. 10. Patients of childbearing age should have effective contraception during the study period.11. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.

Exclusion Criteria:

  • 1. Patients who are receiving concurrent hormonal or cytotoxic therapy or other experimental therapy.

Concurrent therapy with other biological agents, such as Trastuzumab (Herceptin), is not allowed.2. Patients who refuse port-A catheter implantation3.Patients who have received taxane (paclitaxel or docetaxel) or cisplatin as adjuvant chemotherapy.4. Patients with brain or leptomeningeal metastases.5.Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.6.Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.7.Life expectancy less than 2 months. 8.Pregnant or nursing patients may not participate. Patients with reproductive potential may not participate unless they have agreed to use an effective contraceptive method.9.No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00154882

Contacts
Contact: Chiun Hsu, M.D., Ph.D. 886-2-23123456 ext 7009 chiunhsu@ha.mc.ntu.edu.tw
Contact: Yen-Shen Lu, M.D. 886-2-23123456 ext 7009 yslu@ha.mc.ntu.edu.tw

Locations
Taiwan
Department of Oncology , National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yen-Shen Lu, M.D.     886-2-23123456 ext 7009     yslu@ha.mc.ntu.edu.tw    
Sub-Investigator: Sung-Hsin Kuo, M.D.            
Sub-Investigator: Chia-Chi Lin, M.D.            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yen-Shen Lu, M.D. Department of Oncology , National Taiwan University Hospital
  More Information

No publications provided

Study ID Numbers: 920705
Study First Received: September 8, 2005
Last Updated: July 29, 2007
ClinicalTrials.gov Identifier: NCT00154882     History of Changes
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Breast Cancer,First-line

Study placed in the following topic categories:
Radiation-Sensitizing Agents
Cisplatin
Skin Diseases
Paclitaxel
Tubulin Modulators
Breast Neoplasms
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Breast Diseases

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

ClinicalTrials.gov processed this record on September 10, 2009