A Randomized, Controlled Phase III Trial of Picoplatin and Best Supportive Care (BSC) versus BSC Alone in Patients with Small Cell Lung Cancer (SCLC), Refractory or Progressive within Six Months of Completing First-Line, Platinum-Containing Chemotherapy

Poniard Pharmaceuticals, Inc.0 个研究点目标入组 399 人开始时间: 2008年4月8日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方: Poniard Pharmaceuticals, Inc.
入组人数: 399

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

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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.Histological or cytological diagnosis of SCLC or combined SCLC/non-small cell lung cancer (NSCLC) defined as SCLC mixed with squamous cell carcinoma, adenocarcinoma, or large cell carcinoma.
•2.One and only 1 prior cisplatin or carboplatin-containing chemotherapy regimen for SCLC within the scope of the National Comprehensive Cancer Network (NCCN) Guidelines (Section 5.4.1).
•3.Radiological evidence of SCLC that never responded or progressed within 90 days after completion of first-line therapy (refractory); or responded initially to first-line therapy but progressed between 91 and 180 days after treatment was completed (progressed within 91 to 180 days).
•4.CT scans of chest and entire abdomen (including adrenals and full extent of liver) with contrast, preferably within 14 days prior to randomization (up to 21 days is allowed if necessary). MRI is acceptable in the case of allergy to contrast agents. The presence or absence of measurable disease by RECIST must be documented from the baseline CT or MRI scan.
•5.Head CT or MRI scan within 14 days prior to randomization (up to 21 days is allowed if necessary) demonstrating absence of brain metastases.
•6.ECOG PS 0, 1 or 2 within 3 days prior to randomization (Appendix II).
•7.Life expectancy of at least 8 weeks within 3 days prior to randomization.
•8.At least 21 days must have elapsed since the most recent prior chemotherapy dose (42 days for nitrosoureas), with evidence of hematological recovery.
•9.At least 14 days must have elapsed since the most recent prior radiotherapy dose.
•10.At least 14 days must have elapsed since prior surgery except for the placement of venous access device or bronchoscopy.
•11.Subject must be recovered to = Grade 1 toxicity from all non-hematological adverse effects of prior therapies (excluding alopecia).
•12.Age 18 years or over.
•13.ANC = 1.5 x 109/L.
•14.Platelet count = 100 x 109/L.
•15.Hemoglobin of = 90 g/L (transfusion permitted to achieve this hemoglobin).
•16.Aspartate aminotransferase, alanine aminotransferase, and lactate dehydrogenase levels = 2.5 times upper limit of normal (ULN) or = 5 times ULN if liver involvement is present.
•17.Bilirubin of = 1.5 times upper limit of normal (ULN).
•18.Blood urea nitrogen = 1.5 times ULN (hypovolemic subjects may be hydrated to achieve this BUN).
•19.Creatinine clearance of = 50 mL/min, as calculated by the Cockcroft-Gault formula (Appendix III).
•20.Women of childbearing potential must have a negative pregnancy test (serum or urine). Sexually active couples of child-bearing potential must agree to use appropriate birth control methods during chemotherapy and for 3 months after chemotherapy.
•21.Signed informed consent.
•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

•1.Prior radiotherapy that included = 30% of the bone marrow (Appendix IV).
•2.Pleural effusion as the only radiological evidence of SCLC.
•3.Brain or central nervous system (CNS) metastases.
•4.Grade 2 or higher peripheral neuropathy.
•5.Significant cardiac disease, defined as myocardial infarction within 3 months prior to randomization, congestive heart failure classified by the New York Heart Association as Class III or IV (Appendix V), uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.
•6.Serious medical or psychiatric illness that could potentially interfere with the completion of study treatment according to this protocol, e.g., active infection, Crohn’s disease, ulcerative colitis, etc.
•7.Use of other investigational drugs within 30 days prior to randomization.
•8.Breast-feeding.
•9.History of any other malignancy within 5 years, with the exception of treated non-melanoma skin cancer or carcinoma in situ of the cervix.

研究者

发起方

Poniard Pharmaceuticals, Inc.

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