Celecoxib and Docetaxel or Pemetrexed in Treating Patients With Advanced Recurrent Non-Small Cell Lung Cancer

Stopped early · Phase 2

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00520845

Run by

Vanderbilt-Ingram Cancer Center

People needed

23

Starts

2007-10-01

Expected to finish

2014-01-01

Last updated by the study team

2017-03-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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.

Where it is running

• Vanderbilt-Ingram Cancer Center - Cool Springs — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center at Franklin — Nashville, Tennessee, United States
• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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