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临床试验/EUCTR2004-003116-33-DE
EUCTR2004-003116-33-DE进行中（未招募）不适用

A Phase 2 Study to Evaluate the Efficacy and Safety of Palifermin(Recombinant Human Keratinocyte Growth Factor) in the Reduction of Dysphagia in Patients Receiving Concurrent Chemoradiotherapy followed by Consolidation Chemotherapy for Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

Swedish Orphan Biovitrum (Sobi) AB (publ)0 个研究点目标入组 100 人开始时间: 2005年9月26日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
发起方
入组人数
100
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

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

  • •Disease Related:
  • •- Patients with a histologically or cytologically proven diagnosis of NSCLC
  • •- Unresectable (locally advanced) stage IIIa or IIIb disease
  • •- Initial RT field of treatment to encompass = 30% of the esophagus
  • •- Life expectancy = 6 months
  • •- Estimated weight loss = 10% in the 3 months before study randomization
  • •- Measurable disease
  • •Demographic:
  • •- 18 years of age or older
  • •- ECOG performance status of 0-2 (see Appendix F) Screening Laboratory:
  • •- Hemoglobin (hgb) = 10 g/dL without transfusional support or growth factor use in the 4 weeks before study randomization
  • •- Absolute neutrophil count (ANC) = 1.5 x 10e9/L without growth factor use in the 2 weeks before study randomization
  • •- Platelet count = 100 x 10e9/L
  • •- Serum bilirubin = 1.5 x institutional upper limit of normal (ULN)
  • •- Serum creatinine = 2.0 mg/dL (Note: Subjects with a serum creatinine = 1.4 and = 2.0 mg/dL must demonstrate a 24-hour urinary creatinine clearance = 50 mL/min.)
  • •- Females of childbearing potential: negative serum or urine pregnancy test
  • •- Subject must give written informed consent before participating in any study-specific procedure, randomization,
  • •or receiving investigational product.
  • •- Subjects with reproductive capability must agree to practice adequate contraception methods.
  • •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 54
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 46

排除标准

  • •Disease Related:
  • •- Metastatic disease (M1)/stage 4 NSCLC
  • •- Pleural or pericardial effusion greater than 100 ml in volume as documented by appropriate imaging ( PET, CT scan or ultrasound). If an effusion greater than 100 ml is documented by cytology to be free from malignancy and the investigator feels the subject is capable of receiving RT/ CT for their primary disease/ NSCLC, the investigator should discuss the patient with the study physician at Amgen. Effusions smaller than 100 ml would be acceptable, unless the investigator suspects that the effusion is malignant, in which case the effusion should be evaluated by cytology. Sponsor approval must be obtained before subject is randomized.
  • •- Plan to remove the tumor surgically before completing the protocol CT/RT course
  • •- Shielding of any part of the esophagus during RT (including posterior spinal cord shielding)
  • •- Prior chemotherapy, radiotherapy, or surgery for NSCLC
  • •- Prior invasive malignancy during the past 3 years other than non-melanomatous skin cancer. Note: Subjects with prior surgically-cured malignancies [eg, stage I breast cancer or prostate cancer, in-situ carcinoma of the cervix, etc] are not excluded; however, sponsor approval must be obtained before subject is randomized.
  • •- Presence or history of dysphagia or conditions predisposing to dysphagia (eg, uncontrolled gastroesophageal reflux disease [GERD], dyspepsia, etc)
  • •- History of pancreatitis
  • •Medication/Prior Treatment:
  • •- Four weeks or less since completion of treatment using an investigational product/device in another clinical study or presence of any unresolved toxicity from previous treatment
  • •- Previous treatment on this study or with a fibroblast growth factor
  • •Laboratory:
  • •- Known to be sero-positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
  • •- Pregnant or breastfeeding women
  • •- Known sensitivity to E coli derived products
  • •- Compromised ability of the subject to give written informed consent and/or to comply with study procedures
  • •- Refusal to sign an informed consent form to participate in this study, and sign the hospital information release form, if applicable
  • •- Unwilling or unable to complete the PRO questionnaires
  • •- Psychological, social, familial, or geographical reasons that would prevent regular follow-up

研究者

发起方
Swedish Orphan Biovitrum (Sobi) AB (publ)

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