EUCTR2005-005535-10-DE进行中（未招募）不适用
A Phase 2 study of ALIMTA in solid tumor patients with stable third-space fluid
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
- 30
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
- All
入选标准
- •Patients are eligible to be included in this study only if they meet all of the following criteria:
- •[1] Histologic or cytologic diagnosis of locally advanced or metastatic (Stage III or IV at entry) NSCLC that is not amenable to curative therapy or histologic diagnosis of mesothelioma of the pleura or peritoneum that is not amenable to curative therapy.
- •Patients with NSCLC must have been previously treated with one platinum-containing chemotherapy regimen for locally advanced or metastatic disease.
- •Patients with malignant pleural or peritoneal mesothelioma may have received one previous chemotherapy regimen and, at the discretion of the investigator, be clinical candidates for treatment with single-agent pemetrexed.
- •[2] Presence of clinically detectable (by physical exam) and stable-appearing third-space fluid (ascites or pleural effusions).
- •[3] Measurable lesions are not required for enrollment in this study.
- •[4] Prior anticancer treatment (except radiation) must be completed at least 3 weeks prior to study enrollment, and the patient must have recovered from the acute toxic effects of the regimen.
- •[5] Prior radiation therapy is allowed to <25% of the bone marrow. Prior radiation to the whole pelvis is not allowed. Prior radiotherapy must be completed at least 2 weeks before study enrollment, and the patient must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- •[6] An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. (Oken et al. 1982; see Protocol Attachment JMHX.3.)
- •[7] Estimated life expectancy of at least 8 weeks.
- •[8] Patient compliance and geographic proximity that allow adequate follow-up.
- •[9] Adequate organ function that includes the following indices:
- •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 ? the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) ?3.0 ? ULN (ALP, AST, and ALT ?5 ? ULN is acceptable if the liver has tumor involvement).
- •Renal: calculated CrCl >45 mL/min using the original, weight-based Cockcroft and Gault formula (Cockcroft and Gault 1976; see Protocol Attachment JMHX.4). Creatinine clearance enrollment and dosing decisions will be based on local laboratory values. A patient will be enrolled using the local laboratory value. The same local laboratory should be used throughout the study for dosing decisions.
- •[10] Signed informed consent from patient.
- •[11] Males or females at least 18 years of age.
- •[12] Male and female patients with reproductive potential must use an approved contraceptive method if appropriate (for example, intrauterine device, birth control pills, or barrier device) during, and for 6 months after, treatment. Females with childbearing potential must have a negative serum pregnancy test within 7 days before study enrollment.
- •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
- •Patients will be excluded from the study if they meet any of the following criteria:
- •[13] 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.
- •[14] Active infection that, in the opinion of the investigator, would compromise the patient’s ability to tolerate therapy.
- •[15] Pregnant.
- •[16] Breast-feeding.
- •[17] Serious concomitant systemic disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.
- •[18] Second primary malignancy that is clinically detectable at the time of consideration for study enrollment (with the exception of in situ carcinoma of the cervix, adequately treated basal cell carcinoma, and early stage prostate cancer with Gleason grade ?6).
- •[19] Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other than an aspirin dose ?1.3 grams per day, for a 5-day period (8-day period for long-acting agents, such as piroxicam).
- •[20] Brain metastases. Patients who are symptomatic for brain metastases must have a pretreatment computed tomography or magnetic resonance imaging (CT or MRI) of the brain. A patient with documented brain metastases at the time of study entry will be excluded from entering the study. Patients with prior brain metastases may be considered if they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic.
- •[21] Significant weight loss (that is, ?10% of body weight) over the 6 weeks before study entry.
- •[22] Inability or unwillingness to take folic acid, vitamin B12 supplementation, or a corticosteroid.
- •[23] Have previously completed or withdrawn from this study or any other study investigating pemetrexed or have received any prior treatment with pemetrexed.
- •[24] Have been exposed to yellow fever vaccine, and live attenuated vaccines.
- •[25] Are taking oral anticoagulants.
研究者
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