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临床试验/EUCTR2007-000913-13-GB
EUCTR2007-000913-13-GB进行中(未招募)不适用

Phase 2 Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage Small Cell Lung Cancer

Eli Lilly and Company Limited0 个研究点目标入组 55 人开始时间: 2007年6月26日最近更新:
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
55

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

  • [1]Histologic and/or cytologic diagnosis of Limited Stage of Small Cell Lung Cancer, without cytological proven malignant pleural effusion and confined to 1 hemithorax.
  • [2]Performance status of 0 to 1 on the ECOG performance status schedule
  • [3]At least one unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours criteria (at least 10 mm in longest diameter by spiral computerized tomography [CT] scan, or at least 20 mm by standard techniques).
  • [4]Adequate organ function, including the following:
  • Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) =1.5 x 109/L, platelets =100 x 109/L, and haemoglobin = 9 g/dL.
  • Hepatic: bilirubin =1.5 times the upper limit of normal (ULN); alkaline phosphatase (AP), aspartate aminotransferase (AST), and alanine aminotransaminase (ALT) = 3.0 x ULN.
  • Renal: calculated creatinine clearance (CrCl)= 45 mL/min based on the standard Cockcroft and Gault formula.
  • [5]Adequate pulmonary function as defined as a forced expiratory volume in 1 sec (FEV1) >30% predicted normal value and diffusion capacity (DLCO) >40% predicted normal value.
  • [6]Signed informed consent document from patient.
  • [7]Males or females at least 18 years of age.
  • [8]For women: must be surgically sterile, postmenopausal, or compliant with a medically approved contraceptive regimen (for example, intrauterine device, birth control pills, or barrier device) during and for 6 months after the treatment period; must have a negative serum or urine pregnancy test within 7 days before study enrolment and must not be breast-feeding.
  • For men: must be surgically sterile, or compliant with a contraceptive regimen during and for 6 months after the treatment period.
  • [9]Patient compliance and geographic proximity that allows for adequate follow-up.
  • [10]Estimated life expectancy of at least 12 weeks.
  • 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

  • [11]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.
  • [12]Have a serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease, as defined by the New York Heart Association Class III or IV.
  • [13]Diagnosis of a serious concomitant systemic disorder (for example, active infection including HIV) that, in the opinion of the investigator, would compromise the patient’s ability to complete the study.
  • [14]Have had a recent (within 30 days of study treatment) or concurrent yellow fever vaccination.
  • [15]Have had a prior malignancy other than Small Cell Lung 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. Patients with a history of low grade (Gleason score = 6) localized prostate cancer will be eligible even if diagnosed less than 5 years previously.
  • [16]Prior chemotherapy for this cancer and/or prior TRT
  • [17]Pregnancy/breast-feeding.
  • [18]Significant weight loss (that is = 10%) over the previous 6 weeks before study entry.
  • [19]Concurrent administration of any other anti-tumour therapy.
  • [20]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).
  • [21]Inability or unwillingness to take folic acid or vitamin B12 supplementation.
  • [22]Inability to take corticosteroids.
  • [23]Completion or withdrawal from this study or any other study investigating pemetrexed, carboplatin, and/or Thoracic Radiotherapy.
  • [24]Inability or unwillingness to comply with the protocol or study procedures.

研究者

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