Randomized, double-blind, placebo-controlled, multicenter phase ii study of the efficacy and safety of apricoxib in combination with either docetaxel or pemetrexed in patients with biomarker-selected non-small-cell lung cancer

Journal of Clinical Oncology

Volumn 33, Issue 2, 2015, Pages 189-194

  Edelman, Martin J ^a   Tan, Ming T ^b   Fidler, Mary J ^c   Sanborn, Rachel E ^d   Otterson, Greg ^e   Sequist, Lecia V ^f   Evans, Tracey L ^g   Schneider, Bryan J ^h   Keresztes, Roger ⁱ   Rogers, John S ^j   De Mayolo, Jorge Antunez ^k   Feliciano, Josephine ^a   Yang, Yang ^a   Medeiros, Michelle ^a   Zaknoen, Sara L ^l  

^a UNIVERSITY OF MARYLAND   (United States)

^b GEORGETOWN UNIVERSITY   (United States)

^c RUSH UNIVERSITY MEDICAL CENTER   (United States)

^d PROVIDENCE PORTLAND MEDICAL CENTER   (United States)

^e OHIO STATE UNIVERSITY   (United States)

^f MASSACHUSETTS GENERAL HOSPITAL CANCER CENTER   (United States)

^g UNIVERSITY OF PENNSYLVANIA   (United States)

^h WEILL CORNELL MEDICAL COLLEGE   (United States)

ⁱ STONY BROOK UNIVERSITY   (United States)

^j WEST VIRGINIA UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k Mercy Neuroscience Institute   (United States)

^l Tragara Pharmaceuticals   (United States)

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Author keywords

[No Author keywords available]

Indexed keywords

APRICOXIB; CREATININE; CYCLOOXYGENASE 2; DOCETAXEL; PEMETREXED; PROSTAGLANDIN E2; 7-HYDROXY-5,11-DIOXOTETRANORPROSTANE-1,16-DIOIC ACID; ANTINEOPLASTIC AGENT; GLUTAMIC ACID DERIVATIVE; GUANINE; PROSTAGLANDIN; PTGS2 PROTEIN, HUMAN; PYRROLE DERIVATIVE; SULFONAMIDE; TAXOID; TUMOR MARKER;

ACUTE KIDNEY FAILURE; ADULT; ARTICLE; ASEPTIC MENINGITIS; BLADDER NECK STENOSIS; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; COLON PERFORATION; CONFUSION; CONTROLLED STUDY; COUGHING; DECUBITUS; DEEP VEIN THROMBOSIS; DEPRESSION; DIZZINESS; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG SAFETY; DYSPNEA; FAINTNESS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; GENERALIZED EDEMA; HEART MUSCLE ISCHEMIA; HUMAN; HYPERKALEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; LUNG EMBOLISM; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NON SMALL CELL LUNG CANCER; PAIN; PATIENT HISTORY OF CHEMOTHERAPY; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; AGED; ANALOGS AND DERIVATIVES; CANCER STAGING; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIAL; DISEASE FREE SURVIVAL; DOUBLE BLIND PROCEDURE; DRUG ADMINISTRATION; KAPLAN MEIER METHOD; LUNG NEOPLASMS; METABOLISM; MIDDLE AGED; PATHOLOGY; TREATMENT OUTCOME; URINE;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARCINOMA, NON-SMALL-CELL LUNG; CYCLOOXYGENASE 2; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUTAMATES; GUANINE; HUMANS; KAPLAN-MEIER ESTIMATE; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PATIENT SELECTION; PROSTAGLANDINS; PYRROLES; SULFONAMIDES; TAXOIDS; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL;

EID: 84920938211     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.55.5789     Document Type: Article

References (13)

1. Altorki NK, Port JL, Zhang F, et al: Chemotherapy induces the expression of cyclooxygenase-2 in non-small cell lung cancer. Clin Cancer Res 11:4191- 4197, 2005.
2. Edelman MJ, Watson D, Wang X, et al: Eicosanoid modulation in advanced lung cancer: Cyclooxygenase-2 expression is a positive predictive factor for celecoxib + chemotherapy-Cancer and Leukemia Group B Trial 30203. J Clin Oncol 26:848-855, 2008.
3. Fidler MJ, Argiris A, Patel JD, et al: The potential predictive value of cyclooxygenase-2 expression and increased risk of gastrointestinal hemorrhage in advanced non-small cell lung cancer patients treated with erlotinib and celecoxib. Clin Cancer Res 14:2088-2094, 2008.
4. Fabi A, Metro G, Papaldo P, et al: Impact of celecoxib on capecitabine tolerability and activity in pretreated metastatic breast cancer: Results of a phase II study with biomarker evaluation. Cancer Chemother Pharmacol 62:717-725, 2008.
5. Rini BI, Weinberg V, Dunlap S, et al: Maximal COX-2 immunostaining and clinical response to celecoxib and interferon alpha therapy in metastatic renal cell carcinoma. Cancer 106:566-575, 2006.
6. Murphey LJ, Williams MK, Sanchez SC, et al: Quantification of the major urinary metabolite of PGE2 by a liquid chromatographic/mass spectrometric assay: Determination of cyclooxygenasespecific PGE2 synthesis in healthy humans and those with lung cancer. Anal Biochem 334:266-275, 2004.
7. Csiki I, Morrow JD, Sandler A, et al: Targeting cyclooygenase-2 in recurrent non-small cell lung cancer: A phase II trial of celecoxib and docetaxel. Clin Cancer Res 11:6634-6640, 2005.
8. Rao PN, Grover RK: Apricoxib, a COX-2 inhibitor for the potential treatment of pain and cancer. IDrugs 12:711-722, 2009.
9. Howe LR, Subbaramaiah K, Brown AM, et al: Cyclooxygenase-2: A target for the prevention and treatment of breast cancer. Endocr Relat Cancer 8:97-114, 2001.
10. Midgley RS, McConkey CC, Johnstone EC, et al: Phase III randomized trial assessing rofecoxib in the adjuvant setting of colorectal cancer: Final results of the VICTOR trial. J Clin Oncol 28:4575-4580, 2010.
11. Reckamp K, Gitlitz B, Chen LC, et al: Biomarkerbased phase I dose-escalation, pharmacokinetic, and pharmacodynamic study of oral apricoxib in combination with erlotinib in advanced nonsmall cell lung cancer. Cancer 117:809-818, 2011.
12. Gitlitz BJ, Bernstein E, Santos ES, et al: A randomized, placebo-controlled, multicenter, biomarkerselected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Thorac Oncol 9:577-582, 2014.
13. Groen HJ, Sietsma H, Vincent A, et al: Randomized, placebo-controlled phase III study of docetaxel plus carboplatin with celecoxib and cyclooxygenase-2 expression as a biomarker for patients with advanced non-smallcell lung cancer: The NVALT-4 study. J Clin Oncol 29: 4320-4326, 2011.