Phase II study of sorafenib in patients with metastatic or recurrent sarcomas

Journal of Clinical Oncology

Volumn 27, Issue 19, 2009, Pages 3133-3140

  Maki, Robert G ^a   D'Adamo, David R ^a   Keohan, Mary L ^a   Saulle, Michael ^a   Schuetze, Scott M ^a   Undevia, Samir D ^a   Livingston, Michael B ^a   Cooney, Matthew M ^a   Hensley, Martee L ^a   Mita, Monica M ^a   Takimoto, Chris H ^a   Kraft, Andrew S ^a   Elias, Anthony D ^a   Brockstein, Bruce ^a   Blachère, Nathalie E ^a   Edgar, Mark A ^a   Schwartz, Lawrence H ^a   Qin, Li Xuan ^a   Antonescu, Cristina R ^a   Schwartz, Gary K ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALBUMIN; ASPARTATE AMINOTRANSFERASE; HEMOGLOBIN; MITOGEN ACTIVATED PROTEIN KINASE; SORAFENIB; ANTINEOPLASTIC AGENT; BENZENESULFONIC ACID DERIVATIVE; PYRIDINE DERIVATIVE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANGIOSARCOMA; ANTINEOPLASTIC ACTIVITY; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BLISTER; CANCER PATIENT; CLINICAL TRIAL; COHORT ANALYSIS; DESQUAMATION; DIARRHEA; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG WITHDRAWAL; ERYTHEMA MULTIFORME; FATIGUE; FEMALE; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL SYMPTOM; HAND FOOT SYNDROME; HEART EJECTION FRACTION; HEMOGLOBIN BLOOD LEVEL; HUMAN; HYPERBILIRUBINEMIA; HYPERGLYCEMIA; HYPERTENSION; HYPOCALCEMIA; HYPOPHOSPHATEMIA; LEIOMYOSARCOMA; LEUKOPENIA; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALE; MALIGNANT FIBROUS HISTIOCYTOMA; MALIGNANT PERIPHERAL NERVE SHEATH TUMOR; METASTASIS; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NERVE SHEATH TUMOR; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEIN EXPRESSION; RASH; RECURRENT CANCER; SARCOMA; SIDE EFFECT; SKIN TOXICITY; SYNOVIAL SARCOMA; TREATMENT RESPONSE; ADOLESCENT; DISEASE FREE SURVIVAL; KAPLAN MEIER METHOD; MIDDLE AGED; MORTALITY; TUMOR RECURRENCE;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; BENZENESULFONATES; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; KAPLAN-MEIERS ESTIMATE; MALE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PYRIDINES; SARCOMA; YOUNG ADULT;

EID: 67650293850     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2008.20.4495     Document Type: Article

References (40)

1. Brennan MF, Singer S, O'Sullivan B, et al: Soft tissue sarcoma, in DeVita VT Jr, Lawrence TS, Rosenberg SA (eds): Cancer: Principles & Practice of Oncology (ed 8). Philadelphia, PA, Wolters Kluwer, 2008, pp 1741-1794
2. Bay JO, Ray-Coquard I, Fayette J, et al: Docetaxel and gemcitabine combination in 133 advanced soft-tissue sarcomas: A retrospective analysis. Int J Cancer 119:706-711, 2006
3. Hensley ML, Blessing JA, Degeest K, et al: Fixed-dose rate gemcitabine plus docetaxel as second-line therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II study. Gynecol Oncol 109:323-328, 2008
4. Hensley ML, Blessing JA, Mannel R, et al: Fixed-dose rate gemcitabine plus docetaxel as firstline therapy for metastatic uterine leiomyosarcoma: A Gynecologic Oncology Group phase II trial. Gynecol Oncol 109:329-334, 2008
5. Hensley ML, Maki R, Venkatraman E, et al: Gemcitabine and docetaxel in patients with unresectable leiomyosarcoma: Results of a phase II trial. J Clin Oncol 20:2824-2831, 2002
6. Leu KM, Ostruszka LJ, Shewach D, et al: Laboratory and clinical evidence of synergistic cytotoxicity of sequential treatment with gemcitabine followed by docetaxel in the treatment of sarcoma. J Clin Oncol 22:1706-1712, 2004
7. Maki RG, Wathen JK, Patel SR, et al: Randomized phase II study of gemcitabine and docetaxel compared with gemcitabine alone in patients with metastatic soft tissue sarcomas: Results of Sarcoma Alliance for Research through Collaboration study 002. J Clin Oncol 25:2755-2763, 2007
8. Demetri GD, van Oosterom AT, Garrett CR, et al: Efficacy and safety of sunitinib in patients with advanced gastrointestinal stromal tumour after failure of imatinib: A randomised controlled trial. Lancet 368:1329-1338, 2006
9. Verweij J, Casali PG, Zalcberg J, et al: Progression-free survival in gastrointestinal stromal tumours with high-dose imatinib: Randomised trial. Lancet 364:1127-1134, 2004
10. Maki RG, Awan RA, Dixon RH, et al: Differential sensitivity to imatinib of 2 patients with metastatic sarcoma arising from dermatofibrosarcoma protuberans. Int J Cancer 100:623-626, 2002
11. McArthur GA, Demetri GD, van Oosterom A, et al: Molecular and clinical analysis of locally advanced dermatofibrosarcoma protuberans treated with imatinib: Imatinib Target Exploration Consortium Study B2225. J Clin Oncol 23:866-873, 2005
12. Rubin BP, Schuetze SM, Eary JF, et al: Molecular targeting of platelet-derived growth factor B by imatinib mesylate in a patient with metastatic dermatofibrosarcoma protuberans. J Clin Oncol 20: 3586-3591, 2002
13. Chawla SP, Tolcher AW, Staddon AP, et al: Survival results with AP23573, a novel mTOR inhibitor, in patients with advanced soft tissue or bone sarcomas: Update of phase II trial. J Clin Oncol 25:563s, 2007 (suppl; abstr 10076)
14. Mita MM, Mita AC, Chu QS, et al: Phase I trial of the novel mammalian target of rapamycin inhibitor deforolimus (AP23573; MK-8669) administered intravenously daily for 5 days every 2 weeks to patients with advanced malignancies. J Clin Oncol 26:361-367, 2008
15. Okuno SH, Mahoney MR, Bailey HH, et al: A multicenter phase 2 consortium study of the mTOR inhibitor CCI-779 in advanced soft tissue sarcomas. J Clin Oncol 24:9504, 2006
16. Schuetze SM, Baker LH, Maki RG: Sirolimus reduced tumor-related morbidity and resulted in biochemical and radiographic response in patients with progressive sarcoma. J Clin Oncol 24:520s, 2006 (suppl; abstr 9503)
17. Jhanwar SC, Chen Q, Li FP, et al: Cytogenetic analysis of soft tissue sarcomas. Recurrent chromosome abnormalities in malignant peripheral nerve sheath tumors (MPNST). Cancer Genet Cytogenet 78:138-144, 1994
18. Johnson MR, DeClue JE, Felzmann S, et al: Neurofibromin can inhibit Ras-dependent growth by a mechanism independent of its GTPaseaccelerating function. Mol Cell Biol 14:641-645, 1994
19. Mori S, Satoh T, Koide H, et al: Inhibition of Ras/Raf interaction by anti-oncogenic mutants of neurofibromin, the neurofibromatosis type 1 (NF1) gene product, in cell-free systems. J Biol Chem 270:28834-28838, 1995
20. Strumberg D, Richly H, Hilger RA, et al: Phase I clinical and pharmacokinetic study of the Novel Raf kinase and vascular endothelial growth factor receptor inhibitor BAY 43-9006 in patients with advanced refractory solid tumors. J Clin Oncol 23:965-972, 2005
21. Shaffer DR, Leversha MA, Danila DC, et al: Circulating tumor cell analysis in patients with progressive castration-resistant prostate cancer. Clin Cancer Res 13:2023-2029, 2007
22. Ma L, Teruya-Feldstein J, Bonner P, et al: Identification of S664 TSC2 phosphorylation as a marker for extracellular signal-regulated kinase mediated mTOR activation in tuberous sclerosis and human cancer. Cancer Res 67:7106-7112, 2007
23. Agaram NP, Wong GC, Guo T, et al: Novel V600E BRAF mutations in imatinib-naive and imatinib-resistant gastrointestinal stromal tumors. Genes Chromosomes Cancer 47:853-859, 2008
24. Ambrosini G, Cheema HS, Seelman S, et al: Sorafenib inhibits growth and mitogen-activated protein kinase signaling in malignant peripheral nerve sheath cells. Mol Cancer Ther 7:890-896, 2008
25. Simon R: Optimal two-stage designs for phase II clinical trials. Control Clin Trials 10:1-10, 1989
26. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
27. Van Glabbeke M, Verweij J, Judson I, et al: Progression-free rate as the principal end-point for phase II trials in soft-tissue sarcomas. Eur J Cancer 38:543-549, 2002
28. Fata F, O'Reilly E, Ilson D, et al: Paclitaxel in the treatment of patients with angiosarcoma of the scalp or face. Cancer 86:2034-2037, 1999
29. Fury MG, Antonescu CR, Van Zee KJ, et al: A 14-year retrospective review of angiosarcoma: Clinical characteristics, prognostic factors, and treatment outcomes with surgery and chemotherapy. Cancer J 11:241-247, 2005
30. Penel N, Lansiaux A, Adenis A: Angiosarcomas and taxanes. Curr Treat Options Oncol 8:428-434, 2007
31. Skubitz KM, Haddad PA: Paclitaxel and pegylated-liposomal doxorubicin are both active in angiosarcoma. Cancer 104:361-366, 2005
32. Chugh R, Thomas D, Wathen K, et al: Imatinib mesylate in soft tissue and bone sarcomas: Interim results of a Sarcoma Alliance for Research Through Collaboration phase II trial. J Clin Oncol 22:9001, 2004
33. Norden-Zfoni A, Desai J, Manola J, et al: Blood-based biomarkers of SU11248 activity and clinical outcome in patients with metastatic imatinibresistant gastrointestinal stromal tumor. Clin Cancer Res 13:2643-2650, 2007
34. Blay JY, El Sayadi H, Thiesse P, et al: Complete response to imatinib in relapsing pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT). Ann Oncol 19:821-822, 2008
35. Heinrich MC, Joensuu H, Demetri GD, et al: Phase II, open-label study evaluating the activity of imatinib in treating life-threatening malignancies known to be associated with imatinib-sensitive tyrosine kinases. Clin Cancer Res 14:2717-2725, 2008
36. Keohan ML, Morgan JA, D'Adamo DR, et al: Continuous daily dosing of sunitinib in patients with metastatic soft tissue sarcomas other than GIST: Results of a phase II trial. J Clin Oncol 26:10533, 2008
37. Sleijfer S, Papai Z, Le Cesne A, et al: Phase II study of pazopanib (GW786034) in patients with relapsed or refractory soft tissue sarcoma: EORTC 62043. J Clin Oncol 25:552s, 2007 (suppl; abstr 10031)
38. Leong S, Gore L, Benjamin RS, et al: A phase I study of R1507, a human monoclonal antibody IGF1R antagonist given weekly in patients with advanced solid tumors .AACR-NCI-EORTC Molecular Targets Meeting, San Francisco, CA, October 22-26, 2007 (abstr A78)
39. Olmos D, Okuno S, Schuetze SM, et al: Safety, pharmacokinetics and preliminary activity of the anti-IGF-IR antibody CP-751,871 in patients with sarcoma. J Clin Oncol 26:553s, 2008 (suppl; abstr 10501)
40. Thomas D, Chawla SP, Skubitz K, et al: Denosumab treatment of giant cell tumor of bone: Interim analysis of an open-label phase II study. J Clin Oncol 26:553s, 2008 (suppl; abstr 10500)