EUCTR2007-004167-22-HU进行中（未招募）不适用
Paclitaxel poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naive Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol > 30 pg/ml
Cell Therapeutics, Inc.0 个研究点目标入组 450 人开始时间: 2007年11月20日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
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
- Female
入选标准
- •1. Women with baseline estradiol >30 pg/mL (Women on hormone replacement therapy are allowed if baseline estradiol >30 pg/mL).
- •2. Histologically- or cytologically-confirmed diagnosis of NSCLC. (Note: Sputum
- •cytology alone is not acceptable for cell type. Cytologic specimens obtained by
- •brushings, washings, or needle aspiration of a defined lesion or from a pleural
- •effusion are acceptable). Patients may have either measurable or nonmeasurable
- •disease according to RECIST.
- •3. ECOG performance score (PS) of 0, 1, or 2 defined as:
- •0 = Fully active, able to carry on all pre-disease performance without restriction
- •1 = Restricted in physically strenuous activity but ambulatory and able to carry out
- •work of a light or sedentary nature, e.g., light house work, office work
- •2 = Ambulatory and capable of all self-care but unable to carry out any work
- •activities and up and about more than 50% of waking hours.
- •4. Patients must meet one of the following criteria:
- •Recurrent disease following completion of radiation or surgery
- •Stage IIIB who are not candidates for combined modality therapy (primary
- •radiation therapy or surgery), or
- •Stage IV.
- •5. Age =18 years.
- •6. Adequate bone marrow function demonstrated by absolute neutrophil count (ANC)
- •=1.5X 109/L and platelet count =100 X 109/L.
- •7. Hemoglobin =10 g/dL (may be achieved with transfusion).
- •8. Adequate renal function demonstrated by creatinine = 1.5 X the upper limit of normal (ULN).
- •9. Adequate hepatic function demonstrated by all of the following
- •Total bilirubin = 1.5 ULN (CTC grade 1) (patients with Gilbert’s Syndrome or
- •other hereditary bilirubin defects may be included regardless of bilirubin levels)
- •If liver metastases are not present, SGOT and SGPT =2.5 x ULN (CTC grade 0
- •or 1), otherwise SGOT and SGPT must be =5 x ULN (CTC grade 0 to 2).
- •Alkaline phosphatase less than or equal to 2.5 x ULN except for elevated
- •alkaline phosphatase with laboratory documentation that demonstrates bone
- •10. Life expectancy =12 weeks
- •11. Patients with known brain metastases must have received standard antitumor
- •treatment (e.g. whole brain radiation, stereotactic radioablation, or surgery) for their
- •CNS metastases as defined by the site’s institutional standards. Neurologic function
- •must have been stable for 2 weeks before randomization and patients must either be off steroid therapy for their brain metastases or on a tapering regimen. Patients must have recovered from therapy for their brain metastases.
- •12. Patients who have had major surgery must be fully recovered from the surgery.
- •13. Ability to comply with the visit schedule and assessments required by the protocol.
- •14. For patients of reproductive potential, commitment to use adequate contraception during the study and for 6 months after the last dose of study drug.
- •15. Signed approved informed consent, with understanding of study procedures including follow-up for survival.
- •16. Agreement to begin study therapy within 8 calendar days after randomization.
- •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. ECOG performance score (PS) of 0, 1, 3, or 4 defined as:
- •3 = Capable of only limited self-care, confined to bed or chair more than 50% of
- •waking hours
- •4 = Completely disabled. Cannot carry on any self-care. Totally confined to bed or
- •2. Known hypersensitivity to the excipients or the study drug (either CT-2103,
- •paclitaxel, or carboplatin that the patient will receive.
- •3. Evidence of small cell carcinoma, carcinoid, or mixed small cell/non-small cell
- •4. Weight loss >10% in previous 6 months
- •5. LDH > 600 IU/L (central laboratory) regardless of weight loss
- •6. Both LDH > 400 IU/L (central laboratory) and = 5% weight loss in previous 6
- •7. BMI >35
- •8. Any prior systemic chemotherapy for the treatment of lung cancer. This includes
- •systemic radiosensitizers used to treat brain metastases and any biologic agent.
- •9. Local palliative radiotherapy < 7 days before randomization.
- •10. Radiation with curative intent < 30 days before randomization.
- •11. Concurrent primary malignancies except for carcinoma in situ or non-melanoma skin cancer.
- •12. Grade 2 or greater neuropathy.
- •13. Evidence of significant unstable neurological symptoms within the 4 weeks before
- •study randomization. (If unstable neurologic symptoms resulted from brain
- •metastases, patient must meet inclusion criteria number 10).
- •14. Clinically significant active infection for which active therapy is underway.
- •15. Investigational therapy within 4 weeks before randomization, unless local
- •requirements are more stringent.
- •16. Unstable medical conditions including unstable angina or myocardial infarction
- •within the past 6 months before randomization. Patients with evidence of cardiac
- •conduction abnormalities are eligible if their cardiac status is stable.
- •17. Pregnant women or nursing mothers.
- •18. Any circumstance at the time of study entry that would preclude completion of the
- •study or the required follow-up.
研究者
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