EUCTR2006-000441-19-DE进行中（未招募）不适用
A randomised Phase II study of two chemotherapy regimens, Pemetrexed-Carboplatin, and Gemcitabine-vinorelbine, in Anthracycline and Taxane pretreated Advanced Breast cancer patients.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 144
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
- •[1]Females with histologic or cytologic diagnosis of advanced breast cancer. See Protocol Attachment S098.1, American Joint Committee on Cancer Staging Criteria for Breast Cancer (Fleming et al. 1997 ). Lesions should not be amenable to surgery or radiation of curative intent.
- •[2]Performance status of 0 to 2 on the ECOG performance status schedule. See Protocol Attachment S098.2.
- •[3]One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.
- •[4]One prior chemotherapy containing taxanes as (neo)adjuvant or palliative 1st-line treatment.
- •[5]Prior radiation therapy is allowed to <25% of the bone marrow (Cristy and Eckerman, 1987 ). Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
- •[6]At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al 2000): at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques. Positron emission tomography [PET] scans and ultrasounds may not be used
- •[7]Antitumoral hormonal treatment must be discontinued prior to enrollment.
- •[8]Estimated life expectancy of at least 3 months.
- •[9]Patient compliance and geographic proximity that allow adequate follow-up.
- •[10]Adequate organ function including the following:
- •Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ?1.5 ? 109/L, platelets ?100 ? 109/L, and hemoglobin ?9 g/dL.
- •Hepatic: bilirubin ?1.5 times the upper limit of normal (? ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ?3.0 ? ULN (AP, AST, and ALT ?5 ? ULN is acceptable if liver has tumor involvement).
- •Renal: calculated creatinine clearance (CrCl) ?45 mL/min based on the standard Cockcroft and Gault formula [see Protocol Attachment S098.3]. Enrollment and dosing decisions based on creatinine clearance will be made using local lab values. The same lab must be used throughout the study for dosing decisions.
- •[11]Female patients of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
- •[12]Patients must sign an informed consent document.
- •[13]Female patients at least 18 years of age.
- •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
- •[14]Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[15]Have previously completed or withdrawn from this study or any other study investigating Pemetrexed, Gemcitabine, Carboplatin or Vinorelbine
- •[16]Have received more than one line of chemotherapy in MBC. Patients having received more than one combination of A plus T.
- •[17]Are pregnant or breast-feeding.
- •[18]Have serious concomitant systemic disorders (e.g., active infection) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient’s ability to complete the study.
- •[19]Have a prior malignancy other than breast cancer, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- •[20]Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents for a 5-day period (8-day period for long-acting agents such as piroxicam), unless the Creatinine Clearance is = 80 ml/min.
- •[21]Have central nervous system (CNS) metastases.
- •[22]Have clinically relevant (by physical exam) third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry.
- •[23]Are unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.
- •[24]Concurrent administration of any other antitumor therapy.
研究者
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