A phase II study of carboplatin, etoposide, and exisulind in patients with extensive small cell lung cancer CALGB 30104

Journal of Thoracic Oncology

Volumn 4, Issue 2, 2009, Pages 220-226

  Govindan, Ramaswamy ^a,f   Wang, Xiaofei ^b   Baggstrom, Maria Q ^a   Burdette Radoux, Susan ^c   Hodgson, Lydia ^b   Vokes, Everett E ^d   Green, Mark R ^e  

^a USA   (United States)

^b DUKE UNIVERSITY   (United States)

^c UNIVERSITY OF VERMONT COLLEGE OF MEDICINE   (United States)

^d UNIVERSITY OF CHICAGO   (United States)

^e Roper St Francis Healthcare   (United States)

^f WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

CALGB; Carboplatin; Etoposide; Exisulind; Phase II; Small cell lung cancer

Indexed keywords

CARBOPLATIN; ETOPOSIDE; SULINDAC SULFONE; ANTINEOPLASTIC AGENT; DRUG DERIVATIVE; SULINDAC;

ADULT; AGED; ANEMIA; ANOREXIA; ARTICLE; BRAIN ISCHEMIA; BRAIN METASTASIS; CANCER GRADING; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DEHYDRATION; DIARRHEA; DISEASE COURSE; DRUG ACTIVITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; ELECTROLYTE DISTURBANCE; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HEART ARREST; HUMAN; HYPERGLYCEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOTENSION; LEUKOPENIA; LUNG SMALL CELL CANCER; MALE; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PAIN; PANCREATITIS; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SURVIVAL TIME; THROMBOCYTOPENIA; TREATMENT RESPONSE; WEIGHT REDUCTION; CANCER STAGING; LUNG TUMOR; METASTASIS; MIDDLE AGED; MORTALITY; PATHOLOGY; PROGNOSIS; SURVIVAL RATE; TREATMENT OUTCOME;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; ETOPOSIDE; FEMALE; HUMANS; LUNG NEOPLASMS; MALE; MIDDLE AGED; NEOPLASM STAGING; PROGNOSIS; SMALL CELL LUNG CARCINOMA; SULINDAC; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 65649128221     PISSN: 15560864     EISSN: 15561380     Source Type: Journal    
DOI: 10.1097/JTO.0b013e3181951eb0     Document Type: Article

References (39)

1. Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin 2007;57:43- 66.
2. Govindan R, Page N, Morgensztern D, et al. Changing epidemiology of small-cell lung cancer in the United States over the last 30 years: analysis of the surveillance, epidemiologic, and end results database. J Clin Oncol 2006;24:4539-4544.
3. Murray N, Turrisi AT 3rd. A review of first-line treatment for small-cell lung cancer. J Thorac Oncol 2006;1:270-278.
4. Kosmidis PA, Samantas E, Fountzilas G, Pavlidis N, Apostolopoulou F, Skarlos D. Cisplatin/etoposide versus carboplatin/etoposide chemotherapy and irradiation in small cell lung cancer: a randomized phase III study. Hellenic Cooperative Oncology Group for Lung Cancer Trials. Semin Oncol 1994;21:23-30.
5. Piazza GA, Kulchak Rahm AL, Krutzsch M, et al. Antineoplastic drugs sulindac sulfide and sulfone inhibit cell growth by inducing apoptosis. Cancer Res 1995;55:3110-3116.
6. 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 beta-catenin. Cancer Res 2000;60:3338-3342.
7. Duffy CP, Elliott CJ, O'Connor RA, et al. Enhancement of chemotherapeutic drug toxicity to human tumour cells in vitro by a subset of non-steroidal anti-inflammatory drugs (NSAIDs). Eur J Cancer 1998;34:1250-1259.
8. Soriano AF, Helfrich B, Chan DC, Heasley LE, Bunn PA Jr, Chou TC. Synergistic effects of new chemopreventive agents and conventional cytotoxic agents against human lung cancer cell lines. Cancer Res 1999;59:6178-6184.
9. Campling BG, Young LC, Baer KA, et al. Expression of the MRP and MDR1 multidrug resistance genes in small cell lung cancer. Clin Cancer Res 1997;3:115-122.
10. Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst 2000;92:205-216.
11. Calvert AH, Newell DR, Gumbrell LA. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989;7:1748-1756.
12. Cockcroft DW, Gault MW. Prediction of creatinine clearance from serum creatinine. Nephron 1976;13:31-41.
13. Simon GR, Turrisi A. Management of small cell lung cancer: ACCP evidence-based clinical practice guidelines (2nd Edition). Chest 2007;132:324-329.
14. Loehrer PJ, Ansari R, Gonin R, et al. Cisplatin plus etoposide with and without ifosfamide in extensive small-cell lung cancer: a Hoosier Oncology Group Study. J Clin Oncol 1995;13:2594-2599.
15. Miyamoto H, Nakabayashi T, Isobe H, et al. A phase III comparison of etoposide/cisplatin with or without added ifosfamide in small-cell lung cancer. Oncology 1992;29:431-435.
16. Hanna N, Bunn BA Jr, Langer C, 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.
17. Eckardt JR, von Pawel J, Papai Z, et al. Open-label, multicenter, randomized, phase III study comparing oral topotecan/cisplatin versus etoposide/ cisplatin as treatment for chemotherapy-naive patients with extensivedisease small-cell lung cancer. J Clin Oncol 2006;24:2044-2051.
18. Ferraldeschi R, Baka S, Jyoti B, Faivre-Finn C, Thatcher N, Lorigan P. Modern management of small-cell lung cancer. Drugs 2007;67:2135-2152.
19. Giaccone G, Dalesio O, McVie GJ, et al. Maintenance chemotherapy in small-cell lung cancer: long-term results of a randomized trial. J Clin Oncol 1993;11:1230 -1240.
20. Schiller JH, Adak S, Cella D, DeVore RF 3rd, Johnson DH. Topotecan versus observation after cisplatin plus etoposide in extensive-stage small-cell lung cancer: E7593, a phase III trial of the Eastern Cooperative Oncology Group. J Clin Oncol 2001;19:2114 -2122.
21. Bozcuk H, Artac M, Ozdogan M, Savas B. Does maintenance/consolidation chemotherapy have a role in the management of small cell lung cancer (SCLC)? A meta-analysis of the published randomized controlled trials. Cancer 2005;104:2650 -2657.
22. Leyvraz S, Pampallona S, Martinelli G, et al. Randomized phase III study of high-dose sequential chemotherapy (CT) supported by peripheral blood progenitor cells (PBPC) for the treatment of small cell lung cancer (SCLC): results of the EBMT Random-ICE trial. J Clin Oncol ASCO Annu Meet Proc I 2006;24:7064.
23. Board RE, Thatcher N, Lorigan P. Novel therapies for the treatment of small-cell lung cancer: a time for cautious optimism? Drugs 2006;66:1919-1931.
24. Masters GA, Li S, Dowlati A, et al. A phase ii trial of carboplatin and gemcitabine with exisulind (IND #65,056) in patients with advanced non-small cell lung cancer: an Eastern Cooperative Oncology Group Study (E1501). J Thorac Oncol 2006;1:673- 678.
25. Hoang T, Kim KM, Merchant J, et al. Phase I/II study of gemcitabine and exisulind as second-line therapy in patients with advanced non-small cell lung cancer. J Thorac Oncol 2006;1:218 -225.
26. Weiss GJ, Vokes EE, Bunn PA, et al. Docetaxel and exisulind in previously treated non-small cell lung cancer (NSCLC) patients: a Multicenter, Phase II Clinical Trial. J Thorac Oncol 2007;2:933-938.
27. Sinibaldi VJ, Elza-Brown K, Schmidt J, et al. Phase II evaluation of docetaxel plus exisulind in patients with androgen independent prostate carcinoma. Am J Clin Oncol 2006;29:395-398.
28. A Prospective Controlled Phase II Study of Preoperative Exisulind Therapy Initiated Prior to Radical Prostatectomy: effect on Apoptosis, ClinicalTrials.gov identifier: NCT00166478.
29. Prospective, Randomized, Double-Blind Trial of Adjuvant Exisulind Versus Placebo for Patients at Risk for Prostate Cancer Recurrence After Radical Prostatectomy, ClinicalTrials.gov identifier: NCT00166426.
30. Dy GK, Miller AA, Mandrekar SJ, et al. A phase II trial of imatinib (STI571) in patients with c-kit expressing relapsed small-cell lung cancer: a CALGB and NCCTG study. Ann Oncol 2005;16:1811-1816.
31. Moore AM, Einhorn LH, Estes D, et al. Gefitinib in patients with chemo-sensitive and chemo-refractory relapsed small cell lung cancers: a Hoosier Oncology Group phase II trial. Lung Cancer 2006;52:93-97.
32. Shepherd FA, Giaccone G, Seymour L, et al. Prospective, randomized, double-blind, placebo-controlled trial of marimastat after response to first-line therapy in patients with small-cell lung cancer: a trial of the National Cancer Institute of Canada-Clinical Trials Group and the European Organization for Research and Treatment of Cancer. J Clin Oncol 2002;20:4434-4439.
33. Lee SM, Woll PJ, James, LE, et al. A phase III randomised, double blind, placebo controlled trial of etoposide/carboplatin with or without thalidomide in advanced small cell lung cancer (SCLC). J Thorac Oncol 2007;2(Suppl 4):S306, Abstract PRS-04.
34. Sandler A, Szwaric S, Dowlati A, et al. A phase II study of cisplatin (P) plus etoposide (E) plus bevacizumab (B) for previously untreated extensive stage small cell lung cancer (SCLC) (E3501): a trial of the Eastern Cooperative Oncology Group. J Clin Oncol ASCO Annu Meet Proc I 2007;25:7564.
35. Ready N, Dudek AZ, Wang XF, et al. CALGB 30306: a phase II study of cisplatin (C), irinotecan (I) and bevacizumab (B) for untreated extensive stage small cell lung cancer (ES-SCLC). J Clin Oncol ASCO Annu Meet Proc I 2007;25:7563.
36. Aupérin A, Arriagada R, Pignon JP, et al. Prophylactic cranial irradiation for patients with small-cell lung cancer in complete remission. Prophylactic Cranial Irradiation Overview Collaborative Group. N Engl J Med 1999;341:476-484.
37. Slotman B, Faivre-Finn C, Kramer G, et al. Prophylactic cranial irradiation in extensive small-cell lung cancer. N Engl J Med 2007;357:664-672.
38. Velcheti V, Govindan R. Hedgehog signaling and lung cancer. J Thorac Oncol 2007;2:7-10.
39. Watkins DN, Berman DM, Bukholder SG, Wang B, Beachy PA, Baylin SB. Hedgehog signaling within airway epithelial progenitors and in small-cell lung cancer. Nature 2003;422:313-317.