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Sponsored by: |
National Taiwan University Hospital |
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Information provided by: | National Taiwan University Hospital |
ClinicalTrials.gov Identifier: | NCT00154882 |
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 |
Estimated Enrollment: | 43 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | July 2007 |
Arms | Assigned Interventions |
---|---|
A: Experimental | Drug: Paclitaxel ( Phyxol ) , Cisplatin |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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.
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 |
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. |
Principal Investigator: | Yen-Shen Lu, M.D. | Department of Oncology , National Taiwan University Hospital |
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 |
Breast Cancer,First-line |
Radiation-Sensitizing Agents Cisplatin Skin Diseases Paclitaxel Tubulin Modulators |
Breast Neoplasms Antimitotic Agents Antineoplastic Agents, Phytogenic Breast Diseases |
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 |