EUCTR2006-001588-52-DE进行中（未招募）不适用
A randomized phase II trial of pemetrexed with or without PF-3512676 for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of one prior chemotherapy regimen for advanced disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 130
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. Histologically or cytologically confirmed diagnosis of non-small cell lung cancer (NSCLC)
- •2. Locally advanced or metastatic NSCLC not amenable to curative treatment
- •3. Measurable disease defined by at least one lesion that can be accurately measured in at least one dimension as =20 mm with conventional techniques or =10 mm with spiral CT scan within 28 days prior to treatment (RECIST criteria)
- •4. Prior treatment with platinum-based chemotherapy for advanced NSCLC
- •5. Evidence of progressive disease following prior platinum-based chemotherapy
- •6. Prior treatment with only one prior chemotherapy regimen (including adjuvant therapy)
- •- Prior surgery and/or radiotherapy is permitted
- •7. Recovery from all acute toxic effects of prior chemotherapy, radiation therapy and surgery. The interval between completion of these treatments and enrollment into the trial should be at least 2 weeks
- •8. Males or females aged =18 years
- •9. ECOG performance status (PS) 0 or 1
- •10. Adequate organ function as determine by the following criteria:
- •Absolute neutrophil count (ANC) =1.5 x 10 000 000 000/L
- •Platelet count =100 x 10 000 000 000/L
- •Calculated creatinine clearance =45 mL/min using the standard Cockroft
- •and Gault forrmula
- •AST (SGOT) and ALT (SGPT) =3 x ULN, in absence of liver metastasis; AST (SGOT) and ALT (SGPT) = 5 x ULN, in presence of liver metastases
- •Total bilirubin =1.25 x ULN
- •11. Female patients or their partners must be surgically sterile or be postmenopausal, or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. All female patients with reproductive potential must have a negative pregnancy test (serum/urine) within the 72 hours prior to starting treatment. Male patients or their partners must be surgically sterile or must agree to use effective contraception while receiving study treatment and for at least 3 months thereafter. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate
- •12. Provide written, voluntary 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. Any histological/cytological evidence of small cell or carcinoid lung cancer
- •2. Uncontrolled pleural effusion [a controlled pleural effusion is defined as a basal effusion that is radiologically stable for at least 2 weeks]. In patients with clinically significant third space fluid, consideration should be given to draining the effusion prior to pemetrexed administration
- •3. Known central nervous system (CNS) metastasis
- •- CNS imaging is not required at baseline for patients who have no symptoms suggestive of CNS metastases
- •4. Prior neoadjuvant or adjuvant chemotherapy for NSCLC
- •5. Previous radiotherapy to the only site of measurable disease
- •6. Any acute or chronic medical or psychiatric condition or laboratory abnormality that could increase the risk associated with study participation or study drug administration or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study. This includes but is not limited to:
- •- Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, autoimmune thrombocytopenia or glomerulonephritis
- •- History of allogeneic transplant
- •- Untreated and/or uncontrolled superior vena cava syndrome
- •- Untreated and/or uncontrolled hypercalcemia
- •- Requirement for chronic treatment with therapeutic doses of systemic corticosteroids. Use of steroid inhalers, or oral physiologic replacement” doses of corticosteroids is permitted. Physiological replacement doses will be defined as =37.5 mg/day of cortisone, =7.5 mg/day of prednisolone or =1.0 mg/day of dexamethasone. Patients on other replacement regimens must be discussed with the sponsor
- •- Requirement for chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
- •- Uncontrolled hypertension, unstable angina, myocardial infarction or symptomatic congestive heart failure within the past 12 months, or serious uncontrolled cardiac arrhythmia
- •- Active bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV). Serological testing will not be required at baseline for patients who have no symptoms suggestive of infection
- •- Pre-existing peripheral neuropathy > CTCAE Grade 2
- •- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent or compliance with the requirements of the protocol
- •7. History of any active malignancy (other than NSCLC) during the last 3 years except non-melanoma skin cancer, in situ cervical cancer, or cured, early prostate cancer in a patient with PSA level < ULN
- •8. Prior treatment with pemetrexed or PF-3512676 or prior enrollment in another PF-3512676 trial
- •9. Known or suspected hypersensitivity to either of the study drugs (pemetrexed or PF 3512676), study drug classes (antifolates, ODNs) or excipients in the formulation of study drugs
- •10. Female patients who are pregnant or nursing
- •11. Inability or lack of willingness to comply with scheduled visits, therapy plans or laboratory tests
- •12. Current enrollment in another therapeutic clinical trial
- •13. Use of any investigational agent in the past 4 weeks.
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