A phase I trial of sorafenib combined with cisplatin/etoposide or carboplatin/pemetrexed in refractory solid tumor patients

Lung Cancer

Volumn 71, Issue 2, 2011, Pages 151-155

  Davies, Janine M ^a,b   Dhruva, Nirav S ^a   Walko, Christine M ^c   Socinski, Mark A ^a,b   Bernard, Stephen ^a,b   Hayes, D Neil ^a,b   Kim, William Y ^a,b   Ivanova, Anastasia ^b,d   Keller, Kimberly ^b   Hilbun, Layla R ^b   Chiu, Michael ^d   Dees, E Claire ^a,b   Stinchcombe, Thomas E ^a,b  

^a UNIVERSITY OF NORTH CAROLINA SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF NORTH CAROLINA   (United States)

^c University of North Carolina   (United States)

^d IL   (United States)

Author keywords

Non small cell lung cancer; Phase I; Safety and toxicity; Small cell lung cancer; Sorafenib

Indexed keywords

ANTINEOPLASTIC AGENT; APREPITANT; CARBOPLATIN PLUS PEMETREXED; CISPLATIN PLUS ETOPOSIDE; CYANOCOBALAMIN; DEXAMETHASONE; FOLIC ACID; MAGNESIUM SULFATE; MANNITOL; ONDANSETRON; SORAFENIB; UNCLASSIFIED DRUG;

ADULT; AGED; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; ATYPICAL CARCINOID LUNG CANCER; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CARCINOID; CLINICAL ARTICLE; DEHYDRATION; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DRUG DOSE ESCALATION; DRUG ELIMINATION; DRUG FATALITY; DRUG WITHDRAWAL; ESOPHAGUS CANCER; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HEAD AND NECK CARCINOMA; HUMAN; HYPERGLYCEMIA; HYPERTENSION; HYPOGLYCEMIA; HYPOKALEMIA; HYPOMAGNESEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; KIDNEY CARCINOMA; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; MALE; MAXIMUM TOLERATED DOSE; MELANOMA; MUCOEPIDERMOID TUMOR; MULTIPLE CYCLE TREATMENT; NAUSEA; NEPHROTOXICITY; NEUTROPENIA; ONCOCYTOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SALIVARY GLAND MUCOEPIDERMOID; SOLID TUMOR; SQUAMOUS CELL CARCINOMA; STOMACH CANCER; THROMBOCYTOPENIA; THYMOMA; TREATMENT RESPONSE; VOMITING;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; CARBOPLATIN; CARCINOMA, NON-SMALL-CELL LUNG; CARCINOMA, SMALL CELL; CISPLATIN; ETOPOSIDE; FEMALE; GLUTAMATES; GUANINE; HUMANS; LUNG NEOPLASMS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; PYRIDINES; TREATMENT OUTCOME;

EID: 78650953061     PISSN: 01695002     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.lungcan.2010.05.022     Document Type: Article

References (27)

1. Adjei A.A. Targeting multiple signal transduction pathways in lung cancer. Clin Lung Cancer 2005, 7(Suppl. 1):S39-44.
2. Wilhelm S.M., Carter C., Tang L., Wilkie D., McNabola A., Rong H., et al. Trail PA. BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis. Cancer Res 2004, 64:7099-7109.
3. Blumenschein G.R., Gatzemeier U., Fossella F., Stewart D.J., Cupit L., Cihon F., et al. Phase II, multicenter, uncontrolled trial of single-agent sorafenib in patients with relapsed or refractory. Advanced non-small-cell lung cancer. J Clin Oncol 2009.
4. Gitlitz B.J., Glisson B.S., Moon J., Reimers H., Gandara D.R. Sorafenib in patients with platinum (plat) treated extensive stage small cell lung cancer (E-SCLC): a SWOG (S0435) phase II trial. J Clin Oncol 2008, 26. [abstract 8038].
5. Zinner R.G., Fossella F.V., Gladish G.W., Glisson B.S., Blumenschein G.R., Papadimitrakopoulou V.A., et al. Phase II study of pemetrexed in combination with carboplatin in the first-line treatment of advanced nonsmall cell lung cancer. Cancer 2005, 104:2449-2456.
6. Scagliotti G.V., Kortsik C., Dark G.G., Price A., Manegold C., Rosell R., et al. Pemetrexed combined with oxaliplatin or carboplatin as first-line treatment in advanced non-small cell lung cancer: a multicenter, randomized, phase II trial. Clin Cancer Res 2005, 11:690-696.
7. Socinski M.A., Weissman C., Hart L.L., Beck J.T., Choksi J.K., Hanson J.P., et al. Randomized phase II trial of pemetrexed combined with either cisplatin or carboplatin in untreated extensive-stage small-cell lung cancer. J Clin Oncol 2006, 24:4840-4847.
8. Socinski M.A., Smit E.F., Lorigan P., Konduri K., Reck M., Szczesna A., et al. Phase III study of pemetrexed plus carboplatin compared with etoposide plus carboplatin in chemotherapy-naive patients with extensive-stage small-cell lung cancer. J Clin Oncol 2009, 27:4787-4792.
9. Hanna N., Bunn P.A., Langer C., Einhorn L., Guthrie T., Beck T., et al. Randomized phase III trial comparing irinotecan/cisplatin with etoposide/cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer. J Clin Oncol 2006, 24:2038-2043.
10. Lara P.N., Natale R., Crowley J., Lenz H.J., Redman M.W., Carleton J.E., et al. Phase III trial of irinotecan/cisplatin compared with etoposide/cisplatin in extensive-stage small-cell lung cancer: clinical and pharmacogenomic results from SWOG S0124. J Clin Oncol 2009, 27:2530-2535.
11. Eckardt J.R., von Pawel J., Papai Z., Tomova A., Tzekova V., Crofts T.E., et al. Open-label, multicenter, randomized, phase III study comparing oral topotecan/cisplatin versus etoposide/cisplatin as treatment for chemotherapy-naive patients with extensive-disease small-cell lung cancer. J Clin Oncol 2006, 24:2044-2051.
12. Belani C.P., Lee J.S., Socinski M.A., Robert F., Waterhouse D., Rowland K., et al. Randomized phase III trial comparing cisplatin-etoposide to carboplatin-paclitaxel in advanced or metastatic non-small cell lung cancer. Ann Oncol 2005, 16:1069-1075.
13. Therasse P., Arbuck S.G., Eisenhauer E.A., Wanders J., Kaplan R.S., Rubinstein L., et al. New guidelines to evaluate the response to treatment in solid tumors. European Organization for Research and Treatment of Cancer, National Cancer Institute of the United States, National Cancer Institute of Canada. J Natl Cancer Inst 2000, 92:205-216.
14. Calvert A., Newell D., Gumbrell L., O'Reilly S., Burnell M., Boxall F. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989, 7:1748-1756.
15. Pemetrexed package insert.
16. Smith T.J., Khatcheressian J., Lyman G.H., Ozer H., Armitage J.O., Balducci L., et al. 2006 update of recommendations for the use of white blood cell growth factors: an evidence-based clinical practice guideline. J Clin Oncol 2006, 24:3187-3205.
17. Rizzo J.D., Lichtin A.E., Woolf S.H., Seidenfeld J., Bennett C.L., Cella D., et al. Use of epoetin in patients with cancer: evidence-based clinical practice guidelines of the American Society of Clinical Oncology and the American Society of Hematology. J Clin Oncol 2002, 20:4083-4107.
18. Sorafenib prescribing information 2009, Onyx Pharmaceuticals, Emeryville, CA. http://www.nexavar.com/html/download/Nexavar_PI.pdf-accessed3/5/10.
19. Takayama N., Nishikii H., Usui J., Tsukui H., Sawaguchi A., Hiroyama T., et al. Generation of functional platelets from human embryonic stem cells in vitro via ES-sacs. VEGF-promoted structures that concentrate hematopoietic progenitors. Blood 2008, 111:5298-5306.
20. Hanna N.H., von Pawel J., Reck M., Scagliotti G. Carboplatin/paclitaxel with and without sorafenib in chemonaive patients with stage IIIB/IV non-small cell lung cancer: interim analysis results from a randomized phase III trial (ESCAPE). J Thorac Oncol 2008, 3:s268.
21. Scagliotti G., Hanna N., Fossella F., Sugarman K., Blatter J., Peterson P., et al. The differential efficacy of pemetrexed according to NSCLC histology: a review of two Phase III studies. Oncologist 2009, 14:253-263.
22. Scagliotti G.V., Parikh P., von Pawel J., Biesma B., Vansteenkiste J., Manegold C., et al. Phase III study comparing cisplatin plus gemcitabine with cisplatin plus pemetrexed in chemotherapy-naive patients with advanced-stage non-small-cell lung cancer. J Clin Oncol 2008, 26:3543-3551.
23. Ceresoli G.L., Zucali P.A., Favaretto A.G., Grossi F., Bidoli P., Del Conte G., et al. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol 2006, 24:1443-1448.
24. Vogelzang N.J., Rusthoven J.J., Symanowski J., Denham C., Kaukel E., Ruffie P., et al. Phase III study of pemetrexed in combination with cisplatin versus cisplatin alone in patients with malignant pleural mesothelioma. J Clin Oncol 2003, 21:2636-2644.
25. Janne P.A., Wang X.F., Krug L.M., Hodgson L., Vokes E.E., Kindler H.L. Sorafenib in malignant mesothelioma (MM): a phase II trial of the Cancer and Leukemia Group B (CALGB 30307). J Clin Oncol, 2007 ASCO Annual Meeting Proceedings Part I 2007, 25. [abstract 7707].
26. Pivot X., Raymond E., Laguerre B., Degardin M., Cals L., Armand J.P., et al. Pemetrexed disodium in recurrent locally advanced or metastatic squamous cell carcinoma of the head and neck. Br J Cancer 2001, 85:649-655.
27. Elser C., Siu L.L., Winquist E., Agulnik M., Pond G.R., Chin S.F., et al. Phase II trial of sorafenib in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or nasopharyngeal carcinoma. J Clin Oncol 2007, 25:3766-3773.