A Phase II Trial of Celecoxib Plus Chemotherapy [Docetaxel or Pemetrexed] in Patients With Previously Treated, "COX Dependent" Recurrent Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 3
- 主要终点
- Median Survival
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes need for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving celecoxib together with docetaxel or pemetrexed may kill more tumor cells.
PURPOSE: This phase II trial is studying how well celecoxib given together with docetaxel or pemetrexed works in treating patients with advanced or recurrent non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To determine the efficacy of celecoxib when administered with standard chemotherapy comprising docetaxel or pemetrexed disodium in patients with advanced, recurrent non-small cell lung cancer (NSCLC) exhibiting cyclooxygenase (COX) dependence.
Secondary
- To determine the overall response rate and time to progression in patients with COX-dependent recurrent NSCLC treated with celecoxib and docetaxel or pemetrexed disodium.
- To determine the effect of celecoxib on the urinary metabolites of PGE_2 , PGI_2, and thromboxane in patients with COX-dependent recurrent NSCLC.
- To correlate changes in urinary PGE-M and survival with intratumoral expression of COX-2, mPGES, and 15-PGDH as assessed by IHC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •More than two prior chemotherapy regimens for recurrent or relapsed NSCLC.
- •COX Independent as defined by change in urinary PGE-M levels following a "run-in" phase of celecoxib.
- •Previous treatment with both docetaxel and pemetrexed
- •History of greater than grade 2 allergic reaction to celecoxib or any other non-steroid anti-inflammatory agent including aspirin, ibuprofen, or indomethacin.
- •History of allergy to compounds containing boron or mannitol.
- •History of allergy to sulfonamides.
- •Concomitant use of Warfarin, but low dose Coumadin allowed for port prophylaxis
- •Recent (past 4 weeks) coronary artery bypass graft (CABG) surgery.
- •Inadequate organ function:
- •Serum creatinine ≥1.8 mg/dl or a calculated CrCl <45 cc/min.
- •AST >1.5 upper limits of normal (ULN); alkaline phosphatase >2.5 ULN; & bilirubin >1.5 ULN
- •ANC<1500/mm3 & platelets <100,000/mm3
- •Active pregnancy or inability or unwillingness to employ appropriate contraception.
- •Small cell carcinoma histology.
- •Prior malignancy within 5 years of diagnosis of NSCLC. Exceptions include basal cell or non-metastatic squamous cell carcinomas of the skin, cervical carcinoma in situ or FIGO stage I cervical carcinoma, or other cancer history considered not clinically significant by the principal investigator.
研究组 & 干预措施
Treatment Arm
Either docetaxel or pemetrexed given with celecoxib
干预措施: celecoxib (Drug)
Treatment Arm
Either docetaxel or pemetrexed given with celecoxib
干预措施: Docetaxel (Drug)
Treatment Arm
Either docetaxel or pemetrexed given with celecoxib
干预措施: pemetrexed disodium (Drug)
Treatment Arm
Either docetaxel or pemetrexed given with celecoxib
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Median Survival
时间窗: 2 years from date of registration
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)
次要结局
- Time to Progression(2 years from date of registration)
- Overall Response Rate(On-treatment date to date of disease progression (assessed at 6 weeks up to 2 years))
研究者
Leora Horn, MD
Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center