A phase I dose-escalation study to evaluate safety and tolerability of sorafenib combined with sirolimus in patients with advanced solid cancer

British Journal of Cancer

Volumn 103, Issue 11, 2010, Pages 1637-1643

  Desar, I M E ^a   Timmer Bonte, J N H ^a   Burger, D M ^a   Van Der Graaf, W T A ^a   Van Herpen, C M L ^a  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

Author keywords

mTOR inhibitor; phase I; sirolimus; sorafenib; tyrosine kinase inhibitor

Indexed keywords

RAPAMYCIN; SORAFENIB;

ABDOMINAL PAIN; ACNE; ADULT; ALOPECIA; ANEMIA; ANOREXIA; AREA UNDER THE CURVE; ARTICLE; BREAST CANCER; CLINICAL ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONSTIPATION; COUGHING; DIARRHEA; DIZZINESS; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG SAFETY; DRUG TOLERABILITY; DRY SKIN; DYSPHAGIA; FATIGUE; FEMALE; HAND FOOT SYNDROME; HEART MUSCLE ISCHEMIA; HOARSENESS; HUMAN; HYPERCHOLESTEROLEMIA; HYPERTENSION; HYPOALBUMINEMIA; HYPOKALEMIA; HYPOPHOSPHATEMIA; LIVER CELL CARCINOMA; LUNG NON SMALL CELL CANCER; MACULOPAPULAR RASH; MALE; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; NAUSEA; NEUROPATHY; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RASH; SARCOMA; SIDE EFFECT; SKIN PAIN; SOLID TUMOR; THORAX PAIN; THYROID CANCER; TREATMENT RESPONSE; VOMITING; WEIGHT REDUCTION;

ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZENESULFONATES; FEMALE; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; PYRIDINES; SIROLIMUS; TOR SERINE-THREONINE KINASES; VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR-2;

EID: 78650218632     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/sj.bjc.6605777     Document Type: Article

References (27)

1. Abraham RT, Gibbons JJ (2007) The mammalian target of rapamycin signaling pathway: twists and turns in the road to cancer therapy. Clin Cancer Res 13: 3109-3114
2. Azad NS, Posadas EM, Kwitkowski VE, Steinberg SM, Jain L, Annunziata CM, Minasian L, Sarosy G, Kotz HL, Premkumar A, Cao L, McNally D, Chow C, Chen HX, Wright JJ, Figg WD, Kohn EC (2008) Combination targeted therapy with sorafenib and bevacizumab results in enhanced toxicity and antitumor activity. J Clin Oncol 26: 3709-3714
3. Azad NS, ragon-Ching JB, Dahut WL, Gutierrez M, Figg WD, Jain L, Steinberg SM, Turner ML, Kohn EC, Kong HH (2009) Hand-foot skin reaction increases with cumulative sorafenib dose and with combination anti-vascular endothelial growth factor therapy. Clin Cancer Res 15: 1411-1416
4. Bhojani N, Jeldres C, Patard JJ, Perrotte P, Suardi N, Hutterer G, Patenaude F, Oudard S, Karakiewicz PI (2008) Toxicities associated with the administration of sorafenib, sunitinib, and temsirolimus and their management in patients with metastatic renal cell carcinoma. Eur Urol 53: 917-930
5. Cen P, Daleiden A, Doshi G, Amato R (2009) A phase I study of everolimus plus sorafenib in patients with renal cell carcinoma (mRCC). J Clin Oncol 27(e16056): Ref Type: Abstract
6. Dent P, Curiel DT, Fisher PB, Grant S (2009) Synergistic combinations of signaling pathway inhibitors: mechanisms for improved cancer therapy. Drug Resist Updat 12: 65-73
7. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM (2007) Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 356: 125-134
8. Eskens FA, Verweij J (2006) The clinical toxicity profile of vascular endothelial growth factor (VEGF) and vascular endothelial growth factor receptor (VEGFR) targeting angiogenesis inhibitors; a review. Eur J Cancer 42: 3127-3139
9. Faivre S, Delbaldo C, Vera K, Robert C, Lozahic S, Lassau N, Bello C, Deprimo S, Brega N, Massimini G, Armand JP, Scigalla P, Raymond E (2006) Safety, pharmacokinetic, and antitumor activity of SU11248, a novel oral multitarget tyrosine kinase inhibitor, in patients with cancer. J Clin Oncol 24: 25-35
10. Forsythe JA, Jiang BH, Iyer NV, Agani F, Leung SW, Koos RD, Semenza GL (1996) Activation of vascular endothelial growth factor gene transcription by hypoxia-inducible factor 1. Mol Cell Biol 16: 4604-4613
11. Giessinger S, Amato RJ, Jac J, Saxena S, Willis JP, Chiang SB (2008) A phase I study with a daily regimen of the oral mTOR inhibitor RAD001 (everolimus) plus sorafenib for patients with metastatic renal cell cancer (mRCC). J Clin Oncol 26[14603]: Ref Type: Abstract
12. Gotink KJ, Verheul HM (2009) Anti-angiogenic tyrosine kinase inhibitors: what is their mechanism of action? Angiogenesis 13(1): 1-14
13. Harzstark AL, Rosenberg JE, Weinberg VK, Sun J, Ryan J, Lin AM, Fong L, Brocks DR, Small EJ (2009) A phase I study of sorafenib and RAD001 for metastatic clear cell renal cell carcinoma. J Clin Oncol 27(5104): Ref Type: Abstract
14. Kim KB, Davies MA, Papadopoulos NE, Bedikian AY, Hwu W, Woodard KW, Ashington EW, Dancey JE, Wright J, Hwu P (2009) Phase I/II study of the combination of sorafenib and temsirolimus in patients with metastatic melanoma. J Clin Oncol 15s(9026): Ref Type: Abstract
15. Lee JM, Sarosy GA, Annunziata CM, Azad N, Minasian L, Kotz H, Squires J, Houston N, Kohn EC (2010) Combination therapy: intermittent sorafenib with bevacizumab yields activity and decreased toxicity. Br J Cancer 102: 495-499
16. Li J, Kluger H, Saif MW, Murren JR, Lee JJ, Kelly WK, Rink L, Devine L, Sznol MA (2009) Phase I study of sunitinib in combination with sirolimus in adults with advanced refractory malignancies. J Clin Oncol 15s[3554]: Ref Type: Abstract
17. MacDonald A, Scarola J, Burke JT, Zimmerman JJ (2000) Clinical pharmacokinetics and therapeutic drug monitoring of sirolimus. Clin Ther 22(Suppl B): B101-B121
18. Meric-Bernstam F, Gonzalez-Angulo AM (2009) Targeting the mTOR signaling network for cancer therapy. J Clin Oncol 27: 2278-2287
19. Patel PH, Senico PL, Curiel RE, Motzer RJ (2009) Phase I study combining treatment with temsirolimus and sunitinib malate in patients with advanced renal cell carcinoma. Clin Genitourin Cancer 7: 24-27
20. Patnaik A, Ricart A, Cooper J, Papadopoulos K, Beeram M, Mita C, Mita MM, Hufnahel D, Izbicka E, Tolcher A (2007) A phase I, pharmacokinetic and pharmacodynamic study of sorafenib (S), a multi-targeted kinase inhibitor in combination with temsirolimus (T), an mTOR inhibitor in patients with advanced solid malignancies. J Clin Oncol 18s(3512): Ref Type: Abstract
21. Reardon DA, Quinn JA, Vredenburgh JJ, Gururangan S, Friedman AH, Desjardins A, Sathornsumetee S, Herndon JE, Dowell JM, McLendon RE, Provenzale JM, Sampson JH, Smith RP, Swaisland AJ, Ochs JS, Lyons P, Tourt-Uhlig S, Bigner DD, Friedman HS, Rich JN (2006) Phase 1 trial of gefitinib plus sirolimus in adults with recurrent malignant glioma. Clin Cancer Res 12: 860-868
22. Rizell M, Andersson M, Cahlin C, Hafstrom L, Olausson M, Lindner P (2008) Effects of the mTOR inhibitor sirolimus in patients with hepatocellular and cholangiocellular cancer. Int J Clin Oncol 13: 66-70
23. Sosman J, Puzanov I (2009) Combination targeted therapy in advanced renal cell carcinoma. Cancer 115: 2368-2375
24. Stallone G, Schena A, Infante B, Di PS, Loverre A, Maggio G, Ranieri E, Gesualdo L, Schena FP, Grandaliano G (2005) Sirolimus for Kaposi's sarcoma in renal-transplant recipients. N Engl J Med 352: 1317-1323
25. Therasse P, Arbuck SG, Eisenhauer EA, Wanders J, Kaplan RS, Rubinstein L, Verweij J, Van GM, van Oosterom AT, Christian MC, Gwyther SG (2000) 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 92: 205-216
26. van Erp NP, Eechoute K, van der Veldt AA, Haanen JB, Reyners AK, Mathijssen RH, Boven E, van der ST, Baak-Pablo RF, Wessels JA, Guchelaar HJ, Gelderblom H (2009) Pharmacogenetic pathway analysis for determination of sunitinib-induced toxicity. J Clin Oncol 27: 4406-4412
27. Wen PY, Cloughesy T, Kuhn J, Lamborn K, Abrey LE, Lieberman F, Robins HI (2009) Phase I/II study of sorafenib and temsirolimus for patients with recurrent glioblastoma (GBM)(NABTC 05-02). J Clin Oncol 27[2006]: Ref Type: Abstract