EUCTR2005-002428-33-SK进行中（未招募）1 期
A MULTICENTER PHASE 3, RANDOMIZED COMPARISON OF THE SAFETY AND EFFICACY OF WEEKLY TOCOSOL® PACLITAXEL VS. WEEKLY PACLITAXEL INJECTION IN THE TREATMENT OF METASTATIC BREAST CANCER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •a)Female patient with histologic diagnosis of breast carcinoma.
- •b)Stage IV (M1) disease (see Appendix 2).
- •c)No more than one cytotoxic chemotherapy regimen for treatment of MBC. A chemotherapy regimen is defined as a minimum of 2 consecutive cycles of chemotherapy. Such a regimen should preferably have included an anthracycline.
- •d)Adult (18 years of age or older) patients.
- •e)ANC ³ 1,500 cells/mm3, platelets ³ 100,000/mm3 and hemoglobin ³ 10 g/dL.
- •f)Serum creatinine £ 2.5 mg/dL (or £ 221 µmol/L).
- •g)Total bilirubin £ 1.5 times the upper limit of institutional normal values (ULN).
- •h)AST/SGOT and ALT/SGPT £ 2.5 times the ULN.
- •i)PT and PTT within institutional normal range.
- •j)ECOG performance status 0-1 (see Appendix 3).
- •k)At least one unidimensionally measurable lesion as defined by RECIST, assessable by radiographic evaluation (see Section 9.2).
- •l)A signed IRB / Ethics Committee approved Informed Consent.
- •m)Life expectancy of at least 12 weeks.
- •n)Fully recovered from any previous surgery (at least 4 weeks since major surgery).
- •o)If of child bearing potential, a negative pregnancy test within 1 week of randomization. (Such patients must agree to use a medically effective form of contraception during the treatment).
- •p)Agree not to take vitamin E supplementation while receiving study medication, other than vitamin E that may be included in over the counter multi-vitamin supplement.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •a)Patients treated with a taxane within the past 1-year.
- •b)Patients whose tumor tissue is known to show over expression (e.g., FISH analysis = 2 or IHC = 2+) of HER2/neu.
- •c)Bone metastasis, effusions/ascites or elevated serum tumor markers as the only evidence of metastatic disease.
- •d)Brain metastases or neurologic examination suggesting a mass effect.
- •e)Active bowel obstruction.
- •f)Patients who were known to have a cancer of other primary origin (excluding Stage I skin cancer) within the last 5 years or cancer of other primary origin that cannot be histologically distinguished from breast cancer.
- •g)Patients who are pregnant or lactating.
- •h)Peripheral neuropathy NCI-CTCAE Grade 2 or higher.
- •i)Wide-field irradiation within 4 months before first dose of study drug.
- •j)Treatment with a cytotoxic chemotherapy or any investigational agent within 4 weeks, or mitomycin or nitrosoureas within 6 weeks before first dose of study drug.
- •k)Concurrent therapy with warfarin at doses greater than 1 mg/day or equivalent doses of other coumarin derivatives.
- •l)Active infection or any other serious medical condition likely to impair the patient’s ability to tolerate cytotoxic chemotherapy.
- •m) History of hypersensitivity to Cremophor EL or anaphylactoid reaction to taxanes.
- •n)Any circumstance likely to impair the patient’s ability to comply with the requirements of the study protocol.
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