EUCTR2004-000691-13-ES进行中（未招募）1 期
A phase 2 study of ALIMTA plus doxorubicin administered every 21 days in patients with advanced breast cancer
illy S.A.0 个研究点目标入组 70 人开始时间: 2004年11月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 70
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] Histologic or cytologic diagnosis of breast cancer with locally advanced or metastatic disease that is not amenable to local treatment (for example, surgery or radiotherapy).
- •[2] Patients must be chemonaive or have received only neoadjuvant and/or adjuvant chemotherapy.
- •[3] At least one unidimensionally measurable lesion, meeting Response Evaluation Criteria in Solid Tumors (RECIST; Therasse et al. 2000, see Protocol Attachment JMGV.3) criteria (at least 10 mm in longest diameter by spiral computed tomography [(CT]) scan, or at least 20 mm by standard techniques). Ultrasounds and positron emission tomography (PET) scans cannot be used.
- •[4] No chemotherapy is allowed within 4 weeks before enrollment in the study; prior therapy or concomitant therapy with bisphosphonates is allowed, per Section 5.7.7 of this document.
- •[5] Prior endocrine therapy is allowed but must be stopped at the time of enrollment, with the exception of luteinizing hormone-releasing hormone (LH-RH) analogues.
- •[6] Performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale (Oken et al. 1982, see Protocol Attachment JMGV.1).
- •[7] Prior radiation therapy is allowed to <25% of the bone marrow (Cristy and Eckerman 1987), but must be stopped 2 weeks before enrollment in the study.
- •[8] Estimated life expectancy of at least 12 weeks.
- •[9] Patient compliance and geographic proximity that allow for adequate follow-up.
- •[10] Adequate organ function including the following:
- •- adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L, and hemoglobin ³9.0 g/dL
- •- hepatic: bilirubin £1.5 ´ the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) £3.0 ´ ULN (ALP, AST, and ALT £5.0 ´ ULN are acceptable if the liver has tumor involvement)
- •- renal: calculated creatinine clearance (CrCl) ³45 mL/min by using the standard Cockcroft and Gault formula (Cockcroft and Gault 1976, see Protocol Attachment JMGV.2) or the measured glomerular filtration rate (GFR) using the appropriate radiolabeled method (5-CrEDTA or Tc99m-DTPA).
- •[11] Signed informed consent from the patient or legal representative.
- •[12] Women at least 18 years of age.
- •[13] Women must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen during and for 3 months after treatment. Women of childbearing potential must have a negative serum pregnancy test and must not be lactating.
- •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] Prior chemotherapy for advanced breast cancer.
- •[15] Prior treatment with any anthracycline- or anthracenedione-containing regimen.
- •[16] Serious concomitant systemic disorders, including active infection, that would compromise the safety of the patient or compromise the patient’s ability to tolerate and/or complete the study, at the discretion of the investigator.
- •[17] Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of enrollment.
- •[18] Documented brain metastases (unless the patient has completed successful local therapy for central nervous system [CNS] metastases and has not taken corticosteroids for at least 4 weeks before enrollment). Brain imaging is not required in asymptomatic patients, but is required in symptomatic patients to rule out brain metastases.
- •[19] Second primary malignancy (except adequately treated in situ carcinoma of the cervix, adequately treated nonmelanomatous carcinoma of the skin, or other malignancy treated at least 5 years previously with no evidence of recurrence).
- •[20] Significant cardiovascular disease in the form of abnormal electrocardiogram (ECG) or clinical features of recent or recurrent cardiac disease (including myocardial infarction, angina, hypertensive cardiomyopathy, or left ventricular ejection fraction [LVEF] to below the lower limit of normal or an absolute LVEF £45%).
- •[21] Pregnancy and/or breast-feeding.
- •[22] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents (NSAIDs) 2 days before, the day of, and 2 days after the dose of ALIMTA (5 days prior for long-acting agents such as piroxicam).
- •[23] Persons who have previously completed or withdrawn from this study or any other study investigating ALIMTA.
- •[24] Inability or unwillingness to take folic acid, vitamin B12, or dexamethasone supplementation.
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