Status:
UNKNOWN
Paclitaxel (Phyxol) and Cisplatin as First-line Chemotherapy for Metastatic Breast Cancer
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief Summary
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,...
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 i...
Eligibility Criteria
Inclusion
- Women with histologically proven breast cancer and clinical evidence of distant metastasis
- The index lesions should be at least 20 mm × 20 mm in size
- Age must be older than 18 and younger than 75 year-old
- Karnofsky performance status \> 70%
- Adequate bone marrow reserves, defined as white blood cell (WBC) \> 4,000, absolute neutrophil count (ANC) \> 1,500, platelet \> 100,000
- 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
- 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
- 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
- Previous or concurrent radiotherapy is acceptable if the area of radiation does not involve the site of the index tumor lesions
- Patients of childbearing age should have effective contraception during the study period
- 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
- 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
- Patients who refuse port-A catheter implantation
- Patients who have received taxane (paclitaxel or docetaxel) or cisplatin as adjuvant chemotherapy
- Patients with brain or leptomeningeal metastases
- Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry
- Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy
- Life expectancy less than 2 months
- Pregnant or nursing patients may not participate. Patients with reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00154882
Start Date
September 1 2003
End Date
July 1 2007
Last Update
January 21 2010
Active Locations (1)
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1
Department of Oncology , National Taiwan University Hospital
Taipei, Taiwan