EUCTR2005-001224-36-IT进行中（未招募）不适用
A PHASE 1B DOSE ESCALATION/PHASE 2 RANDOMIZED, NON-COMPARATIVE, MULTIPLE CENTER, OPEN LABEL STUDY OF CP-751,871 IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN AND OF PACLITAXEL AND CARBOPLATIN ALONE AS FIRST LINE TREATMENT FOR ADVANCED NONSMALL CELL LUNG CANCER - ND
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 入组人数
- 190
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 documented Stage IIIB NSCLC with a pleural or pericardial effusion or multiple ipsilateral lung nodules, or Stage IV NSCLC, or recurrent previous surgery and radiation allowed disease, based on the current Tumor Nodal Metastasis TNM classification Appendix E . This includes the histologic sub-types of squamous cell, adenocarcinoma, large cell, anaplastic cell, bronchoalveolar, and NSCLC not otherwise specified NOS . Mixed tumors will be classified according to the predominant cell type; tumors with the presence of small cell elements are ineligible. Sputum cytology is not acceptable for cell type classification. Note Radiation to the only site of measurable disease will deem the patient ineligible unless progression of the site after completion of radiation is documented. 2. Measurable disease defined by at least one lesion that can be accurately measured and whose size is 2 cm by conventional radiologic techniques or 1 cm by spiral CT scan. Baseline measurements/evaluations must be completed within 21 days prior to dosing. 3. Adequate bone marrow, hepatic, renal, and cardiac function documented within 14 days prior to enrollment/randomization a. absolute neutrophil count neutrophils and bands 1.5 x 10 9 cells/L b. platelets 100 x 10 9 cells /L c. AST and ALT 5.0 x the upper limit of normal ULN d. total bilirubin 1.5 x ULN serum creatinine 1.5 x ULN or calculated creatinine clearance 60 ml/min f. serum albumin 2.7 g/dL g. 12-lead electrocardiogram ECG with normal tracing, or non-clinically significant changes that do not require medical intervention. h. No history of mitral valve abnormalities 4. Age 18 years. 5. ECOG performance status of 0 or 1 Appendix F 6. Females must be either not of childbearing potential surgically sterilized or at least two years postmenopausal . or if of childbearing potential using an adequate method of contraception, which includes at least one of the following oral, implanted, injectable contraceptive hormones, or mechanical products such as an intrauterine device or barrier methods diaphragm, condoms, spermicides to prevent pregnancy or practicing abstinence or have a partner that is sterile eg, vasectomy . Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of study therapy. 7. Written and voluntary informed consent 8. Life expectancy 3 months 9. Adequate IV access
- •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 prior chemotherapy, biologic response modifiers or investigational therapy including previous adjuvant or neoadjuvant chemotherapy. 2. Prior radiotherapy within a week prior to first study treatment if to them only site of measurable disease unless there is documented progression of the irradiated site see Appendix D . 3. Gastrointestinal abnormalities including active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy. 4. Symptomatic brain metastases. Brain metastases stable for 2 weeks before dosing or requiring concurrent steroid therapy or with clinical symptoms. Clinical symptoms suggestive of new brain metastasis within 2 weeks of enrollment. If such evidence exists, new brain metastasis must be ruled out by a CT scan or MRI. Patients that develop brain metastasis during the study may have treatment interrupted to receive a course of cranial radiation and restart study treatment after a recovery period of one week. 5. A serious uncontrolled medical disorder or active infection, which would impair their ability to receive study treatment. History of HIV screening test not required . 6. Significant active cardiac disease including uncontrolled high blood pressure, unstable angina, uncompensated congestive heart failure, myocardial infarction within the previous 6 months, or serious cardiac ventricular arrhythmias. 7. Patients who are receiving chronic steroid therapy. Use of high dose corticosteroids 100 mg of prednisone per day or 40 mg dexamethasone per day within 1 week prior to treatment. Previous steroid treatment or low dose steroid use for the control of nausea and vomiting will be allowed. Use of antiemetics for the treatment of nausea and vomiting will be allowed at the discretion of the investigator. 8. Neuropathy greater than grade 1 or evidence of unstable neurological symptoms within the past 4 weeks. Concurrent use of growth hormones or growth hormone inhibitors or aminoglycoside antibiotics. Interventional use of growth factors is allowed in the case of febrile neutropenia or when severe myelosuppression is complicated by a suspected infection, if deemed necessary by the investigator. Prophylactic use of growth factors will be allowed in cases of recurrent febrile neutropenia, recurrent afebrile neutropenia with a suspected underlying infection. Prophylactic or therapeutic use of erythropoietin will be permitted. Patients will be pre-medicated prior to the use of paclitaxel. 10. Known or suspected hypersensitivity to agents that contain Cremophor polyoxyethylated castor oil in their formulation or mannitol. Medical contraindications to any of the pre-medications required for paclitaxel infusion. 11. A history of an active malignancy other than NSCLC during the last 3 years except nonmelanomatous skin cancer or in situ breast or cervical cancer. Breast cancer prevention treatment with hormonal agents will be permitted. 12. Major surgical procedure within 4 weeks of study drug administration. Local radiation within 1 week of study drug administration. 13. Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol. 14. Women who are pregnant or breast-feeding. WOCBP or fertile males not using an adequate method of birth control
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