NCT00932152终止2 期
A Phase II Randomized Trial of Fulvestrant and Anastrozole as Consolidation Therapy in Postmenopausal Women With Advanced Non-small Cell Lung Cancer Who Have Received First-line Platinum-based Chemotherapy With or Without Bevacizumab
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- To Evaluate the Progression-free Survival.
研究概览
简要总结
This research study will test whether dual anti-estrogen therapy (anastrozole and fulvestrant) slows the time to when the cancer progresses.
详细描述
Women invited to participate in this study must be post-menopausal and be 18 years of age or older. The study is being performed on a total of 100 individuals. Of this group, 75 will be in the Treatment Groups using Fulvestrant/Anastrozole with our without bevacizumab and 25 will be in the "Best Supportive Care" groups receiving no treatment or just bevacizumab at the University of Pittsburgh Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic diagnosis of non-small cell lung cancer (NSCLC) (no component of small cell).
- •Patients must have stage IIIB (with malignant pleural effusion), stage IV NSCLC (as staged by the AJCC Cancer Staging Manual. 6th ed, appendix 1) or stage IV NSCLC as staged by the new AJCC staging system
- •Patients with recurrent NSCLC should have recurred 12 months or more after completion of prior chemotherapy given in the context of curative therapy (chemoradiotherapy or adjuvant therapy) are eligible
- •Patients should have been treated with 4 cycles of induction chemotherapy utilizing the following regimens: carboplatin/paclitaxel, carboplatin/gemcitabine, carboplatin/paclitaxel + bevacizumab, carboplatin/gemcitabine + bevacizumab, or carboplatin/pemetrexed +/- bevacizumab, (see Section 3.2 for acceptable doses and schedules) and should have CR, PR, or SD as best response.
- •Patients should not have progressed on prior chemotherapy for metastatic or recurrent NSCLC.
- •Must be postmenopausal female, as defined by the following criteria:
- •Prior bilateral oophorectomy or
- •Age greater than 60 years old
- •Age less than 60 years old and amenorrheic for 12 or more months in the absence of chemotherapy or ovarian suppression with FSH and estradiol in the postmenopausal range.
- •Registration/randomization should be within 6 weeks of beginning of last cycle of chemotherapy
- •Documented evidence of a tumor response of CR, PR, or SD. Tumor assessment must occur between Cycle 4 (Day 1) of induction therapy and the date of randomization. Tumor assessment will be per RECIST (Appendix 3) by the treating physician. This response does not have to be confirmed in order for the patient to be randomized; however, unconfirmed responses will be stratified in the stable disease strata. Positron emission tomography (PET) scans and ultrasound may not be used for lesion measurements for response determination
- •ECOG performance status 0, 1 or
- •At least 18 years of age.
- •Adequate organ function, including the following:
- •Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) greater than or equal to 1.0 x10^9/L, platelets greater than or equal to 75 x10^9/L, and hemoglobin greater than or equal to 9 g/dL.
- •Hepatic: bilirubin less than or equal to 1.5 times the upper limit of normal (ULN), alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) less than or equal to 2.0 Renal: calculated creatinine clearance (CrCl) ≥45 mL/min based on the standard Cockcroft and Gault formula (Cockcroft and Gault 1976).
- •Prior radiotherapy must be completed at least 3 weeks before study enrollment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrollment.
- •Signed informed consent document on file.
- •Patient compliance and geographic proximity that allow adequate follow up.
- •Patient must receive on-study therapy no earlier than 21 days and no later than 42 days from their last cycle (Day 1) of induction therapy.
- •Patients must have archival tissue samples. Tumor tissue will be submitted for assessment of ERa, ERb, PR, VEGF and aromatase expression. The patient must also agree to mandatory correlative blood samples at baseline, 5 weeks, 9 weeks, 13 weeks and at the time of progression.
- •Cisplatin may be used instead of carboplatin as part of the initial induction chemotherapy regimen, at the discretion of the treating physician investigator. The dose and schedule of cisplatin will be according to the standard of care for patients with stage IIIB with malignant pleural effusion or stage IV NSCLC as staged by the AJCC Cancer Staging Manual, 6th ed, appendix 1, that is equivalent to stage IV NSCLC as staged by the new 7th ed AJCC staging system.
排除标准
- •Male gender
- •With the exception of those chemotherapies listed as Inclusion criterion (4) No other concomitant biological therapy (e.g. cetuximab) is allowed.
- •Have received experimental treatment within the last 30 days at the time of study entry.
- •Inability to comply with protocol or study procedures.
- •A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
- •Concurrent administration of any other antitumor therapy (except arm B, who are allowed to continue with bevacizumab).
- •Pregnant or breast feeding.
- •Have a prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
- •Patients with two or more deep vein thromboses, or an active deep vein thrombosis.
- •Patients taking hormone replacement therapy or other hormonal therapies
- •The International Normalized Ratio (INR) must be < 1.6 within 28 days prior to registration.
- •Patients with bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or a history of recent history of hemoptysis (1/2 tsp of red blood). Patients on stable long term anticoagulation prior to starting this trial are allowed.
- •History of hypersensitivity to active or inactive excipients of fulvestrant (ie castor oil or Mannitol).
- •Treatment of NSCLC with squamous cell histology with bevacizumab.
- •No progressive Brain or CNS metastases
- •No other concurrent anticancer therapy is allowed other than Bevacizumab
研究组 & 干预措施
Arm B, Group 1
Active Comparator
Best supportive care only: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, and/or nutritional support PRN
干预措施: Best supportive care (Drug)
Arm B, Group 2
Active Comparator
Best supportive care and Bevacizumab 15mg/kg every 21 days
干预措施: Bevacizumab (Avastin) (Drug)
Arm B, Group 2
Active Comparator
Best supportive care and Bevacizumab 15mg/kg every 21 days
干预措施: Best supportive care (Drug)
Arm A, Group 1
Experimental
Fulvestrant and anastrozole only
干预措施: fulvestrant (Faslodex) (Drug)
Arm A, Group 1
Experimental
Fulvestrant and anastrozole only
干预措施: anastrozole (Arimidex) (Drug)
Arm A, Group 2
Experimental
Fulvestrant, anastrozole and Bevacizumab
干预措施: fulvestrant (Faslodex) (Drug)
Arm A, Group 2
Experimental
Fulvestrant, anastrozole and Bevacizumab
干预措施: anastrozole (Arimidex) (Drug)
Arm A, Group 2
Experimental
Fulvestrant, anastrozole and Bevacizumab
干预措施: Bevacizumab (Avastin) (Drug)
结局指标
主要结局
To Evaluate the Progression-free Survival.
时间窗: 1.5 years
次要结局
- To Evaluate the Levels of 17b-estradiol, VEGF, E-selectin, Thrombospondin-1 and IGF-1, and Other Biomarkers in the Plasma.(1.5 years)
- To Evaluate Biomarkers (ERa, ERb, PR, VEGF and Aromatase Expression) in Baseline, Archival Tumor Tissue and Correlate Their Expression With Progression-free Survival, Time to Progression, and Overall Survival.(1.5 years)
- To Evaluate the Time to Overall Survival, Time to Progression, and Toxicities(1.5 years)
研究者
Ahmad Tarhini
Associate Professor of Medicine and Translational Science
University of Pittsburgh
研究点 (1)
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