A phase I/II study fo exisulind in combination with docetaxel/carboplatin in patients with metastatic non-small-cell lung cancer

Clinical Lung Cancer

Volumn 6, Issue 6, 2005, Pages 361-366

  Jones, Suzanne F ^a   Kuhn, John G ^b   Greco, F Anthony ^a   Raefsky, Eric L ^a   Hainsworth, John D ^a   Dickson, Natalie R ^a   Thompson, Dana S ^a   Willcutt, Noel T ^a   White, Melissa B ^a   Burris III, Howard A ^a  

^a SARAH CANNON RESEARCH INSTITUTE   (United States)

^b University of Texas Health Science Center   (United States)

Author keywords

Combination therapy; Pharmacokinetics; Platinum compounds; Sulfone derivatives; Taxanes

Indexed keywords

AMINOTRANSFERASE; BILIRUBIN; CARBOPLATIN; COLONY STIMULATING FACTOR; DOCETAXEL; ERYTHROPOIETIN; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; SULINDAC SULFONE;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ADULT; AGED; ANEMIA; ANOREXIA; ANTINEOPLASTIC ACTIVITY; APOPTOSIS; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; BLOOD TOXICITY; BONE MARROW SUPPRESSION; CANCER SURVIVAL; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG ELIMINATION; DRUG ERUPTION; DRUG FATALITY; DRUG HYPERSENSITIVITY; DRUG METABOLISM; DRUG POTENTIATION; DRUG SAFETY; EDEMA; ESOPHAGITIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; LIVER DYSFUNCTION; LUNG NON SMALL CELL CANCER; MAJOR CLINICAL STUDY; MALE; METASTASIS POTENTIAL; MUCOSA INFLAMMATION; MYALGIA; NAIL DISEASE; NAUSEA; NEUROPATHY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; SEPSIS; STOMATITIS; SURVIVAL RATE; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; VOMITING;

EID: 26444491702     PISSN: 15257304     EISSN: None     Source Type: Journal    
DOI: 10.3816/CLC.2005.n.016     Document Type: Article

References (13)

1. Piazza GA, Rahm AK, Fin TS, et al. Apoptosis primarily accounts for the growth-inhibitory properties of sulindac metabolites and involves a mechanism that is independent of cylcooxygenase inhibition, cell cycle arrest and p53 induction. Cancer Res 1997; 57:2452-2459.
2. Thompson WJ, Piazza GA, Li H, et al. Exisulind induction of apoptosis involves guanosine 3′,5′-cyclic monophosphate phosphodiesterase inhibition, protein kinase G activation, and attenuated b-catenin. Cancer Res 2000; 60:3338-3342.
3. Malkinson AM, Koski KM, Dwyer-Nield LD, et al. Inhibition of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone-induced mouse lung tumor formation by FGN-1 (sulindac sulfone). Carcinogenesis 1998; 19:1353-1356.
4. Chan DC, Earle KA, Zhao TLM, et al. Exisulind in combination with docetaxel inhibits growth and metastasis of human lung cancer and prolongs survival in athymic nude rats with orthotopic lung tumors. Clin Cancer Res 2002; 8:904-912.
5. Whitehead CM, Earle KA, Fetter J, et al. Exisulind-induced apoptosis in a non-small cell lung cancer orthotopic lung tumor model augments docetaxel treatment and contributes to increased survival. Mol Cancer Ther 2003; 2:479-488.
6. Ramalingam S, Dobbs TW, Einzig AI, et al. Carboplatin and docetaxel in advanced non-small-cell lung cancer: results of a multicenter phase II study. Cancer Chemother Pharmacol 2004; 53:439-444.
7. Fossella F, Pereira JR, von Pawel J, et al. Randomized, multinational, phase III study of docetaxel plus platinum combinations versus vinorelbine plus cisplatin for advanced non-small-cell lung cancer the TAX 326 study group. J Clin Oncol 2003; 21:3016-3024.
8. Green S and Weiss GR. Southwest Oncology Group standard response criteria, end-point definitions and toxicity criteria. Invest New Drugs 1992; 10:239-253.
9. Burris H, Irvin R, Kuhn J, et al. Phase I clinical trial of Taxotere administered as either a 2-hour or 6-hour intravenous infusion. J Clin Oncol 1993; 11:950-958.
10. Von Stolk R, Stoner G, Hayton WL, et al. Phase I trial of exisulind (sulindac sulfone, FGN-1) as a chemopreventive agent in patients with familial adenomatous polyposis. Clin Cancer Res 2000; 6:78-89.
11. Jones SF, Kuhn JG, Raefsky EL, et al. A phase I study of exisulind in combination with docetaxel/carboplatin in patients with non-small cell lung cancer. Proc Am Soc Clin Oncol 2002; 21:329a (Abstract #1314).
12. Tolcher AW, Kuhn J, Schwartz G, et al. A phase I pharmacokinetic and biological correlative study of oblimersen sodium (Genasense, G3139), an antisense oligonucleotide to the Bcl-2 mRNA, and of docetaxel in patients with hormone-refractory prostate cancer. Clin Cancer Res 2004; 10:5048-5057.
13. OSI Pharmaceuticals, Inc. Aptosyn in combination with taxotere in advanced non-small cell lung cancer does not meet endpoints [press release]; June 11, 2004. Melville, NY: OSI Pharmaceuticals, 2004.