Perioperative Chemotherapy With Bevacizumab for Colorectal Carcinomatosis

Summary

The Bev-IP trial is designed to assess the feasibility and efficacy of a combined treatment consisting of perioperative combination chemotherapy with the vascular endothelial growth factor A inhibitor bevacizumab and cytoreductive surgery with intraperitoneal oxaliplatin.

Timeline

Start

2015-11-04

Primary completion

2023-11-09

Completion

2023-11-09

Publications

• Background Herszenyi L, Tulassay Z. Epidemiology of gastrointestinal and liver tumors. Eur Rev Med Pharmacol Sci. 2010 Apr;14(4):249-58.
• Background Peeters M, Price T. Biologic therapies in the metastatic colorectal cancer treatment continuum--applying current evidence to clinical practice. Cancer Treat Rev. 2012 Aug;38(5):397-406. doi: 10.1016/j.ctrv.2011.08.002. Epub 2011 Sep 6.
• Background Klaver YL, Simkens LH, Lemmens VE, Koopman M, Teerenstra S, Bleichrodt RP, de Hingh IH, Punt CJ. Outcomes of colorectal cancer patients with peritoneal carcinomatosis treated with chemotherapy with and without targeted therapy. Eur J Surg Oncol. 2012 Jul;38(7):617-23. doi: 10.1016/j.ejso.2012.03.008. Epub 2012 May 8.
• Background Koppe MJ, Boerman OC, Oyen WJ, Bleichrodt RP. Peritoneal carcinomatosis of colorectal origin: incidence and current treatment strategies. Ann Surg. 2006 Feb;243(2):212-22. doi: 10.1097/01.sla.0000197702.46394.16.
• Background Segelman J, Granath F, Holm T, Machado M, Mahteme H, Martling A. Incidence, prevalence and risk factors for peritoneal carcinomatosis from colorectal cancer. Br J Surg. 2012 May;99(5):699-705. doi: 10.1002/bjs.8679. Epub 2012 Jan 27.
• Background Lemmens VE, Klaver YL, Verwaal VJ, Rutten HJ, Coebergh JW, de Hingh IH. Predictors and survival of synchronous peritoneal carcinomatosis of colorectal origin: a population-based study. Int J Cancer. 2011 Jun 1;128(11):2717-25. doi: 10.1002/ijc.25596. Epub 2010 Oct 13.
• Background Tran B, Kopetz S, Tie J, Gibbs P, Jiang ZQ, Lieu CH, Agarwal A, Maru DM, Sieber O, Desai J. Impact of BRAF mutation and microsatellite instability on the pattern of metastatic spread and prognosis in metastatic colorectal cancer. Cancer. 2011 Oct 15;117(20):4623-32. doi: 10.1002/cncr.26086. Epub 2011 Mar 31.
• Background Sadeghi B, Arvieux C, Glehen O, Beaujard AC, Rivoire M, Baulieux J, Fontaumard E, Brachet A, Caillot JL, Faure JL, Porcheron J, Peix JL, Francois Y, Vignal J, Gilly FN. Peritoneal carcinomatosis from non-gynecologic malignancies: results of the EVOCAPE 1 multicentric prospective study. Cancer. 2000 Jan 15;88(2):358-63. doi: 10.1002/(sici)1097-0142(20000115)88:23.0.co;2-o.
• Background Pelz JO, Chua TC, Esquivel J, Stojadinovic A, Doerfer J, Morris DL, Maeder U, Germer CT, Kerscher AG. Evaluation of best supportive care and systemic chemotherapy as treatment stratified according to the retrospective peritoneal surface disease severity score (PSDSS) for peritoneal carcinomatosis of colorectal origin. BMC Cancer. 2010 Dec 22;10:689. doi: 10.1186/1471-2407-10-689.
• Background Franko J, Shi Q, Goldman CD, Pockaj BA, Nelson GD, Goldberg RM, Pitot HC, Grothey A, Alberts SR, Sargent DJ. Treatment of colorectal peritoneal carcinomatosis with systemic chemotherapy: a pooled analysis of north central cancer treatment group phase III trials N9741 and N9841. J Clin Oncol. 2012 Jan 20;30(3):263-7. doi: 10.1200/JCO.2011.37.1039. Epub 2011 Dec 12.
• Background Euler J, Priesching A, Wenzl J, Sauermann G, Klockler K, Kretschmer G. [Hyperthermic peritoneal perfusion in ascites tumours in rats (author's transl)]. Wien Klin Wochenschr. 1974 Apr 19;86(8):220-5. No abstract available. German.
• Background Spratt JS, Adcock RA, Muskovin M, Sherrill W, McKeown J. Clinical delivery system for intraperitoneal hyperthermic chemotherapy. Cancer Res. 1980 Feb;40(2):256-60.
• Background Hildebrandt B, Wust P, Ahlers O, Dieing A, Sreenivasa G, Kerner T, Felix R, Riess H. The cellular and molecular basis of hyperthermia. Crit Rev Oncol Hematol. 2002 Jul;43(1):33-56. doi: 10.1016/s1040-8428(01)00179-2.
• Background Raaphorst GP, Yang DP. The evaluation of thermal cisplatin sensitization in normal and XP human cells using mild hyperthermia at 40 and 41 degrees C. Anticancer Res. 2005 Jul-Aug;25(4):2649-53.
• Background Los G, Sminia P, Wondergem J, Mutsaers PH, Havemen J, ten Bokkel Huinink D, Smals O, Gonzalez-Gonzalez D, McVie JG. Optimisation of intraperitoneal cisplatin therapy with regional hyperthermia in rats. Eur J Cancer. 1991;27(4):472-7. doi: 10.1016/0277-5379(91)90389-u.
• Background Verwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA. Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol. 2003 Oct 15;21(20):3737-43. doi: 10.1200/JCO.2003.04.187.
• Background Verwaal VJ, Bruin S, Boot H, van Slooten G, van Tinteren H. 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol. 2008 Sep;15(9):2426-32. doi: 10.1245/s10434-008-9966-2. Epub 2008 Jun 3.
• Background Glehen O, Kwiatkowski F, Sugarbaker PH, Elias D, Levine EA, De Simone M, Barone R, Yonemura Y, Cavaliere F, Quenet F, Gutman M, Tentes AA, Lorimier G, Bernard JL, Bereder JM, Porcheron J, Gomez-Portilla A, Shen P, Deraco M, Rat P. Cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for the management of peritoneal carcinomatosis from colorectal cancer: a multi-institutional study. J Clin Oncol. 2004 Aug 15;22(16):3284-92. doi: 10.1200/JCO.2004.10.012.
• Background Yan TD, Black D, Savady R, Sugarbaker PH. Systematic review on the efficacy of cytoreductive surgery combined with perioperative intraperitoneal chemotherapy for peritoneal carcinomatosis from colorectal carcinoma. J Clin Oncol. 2006 Aug 20;24(24):4011-9. doi: 10.1200/JCO.2006.07.1142.
• Background Hompes D, D'Hoore A, Van Cutsem E, Fieuws S, Ceelen W, Peeters M, Van der Speeten K, Bertrand C, Legendre H, Kerger J. The treatment of peritoneal carcinomatosis of colorectal cancer with complete cytoreductive surgery and hyperthermic intraperitoneal peroperative chemotherapy (HIPEC) with oxaliplatin: a Belgian multicentre prospective phase II clinical study. Ann Surg Oncol. 2012 Jul;19(7):2186-94. doi: 10.1245/s10434-012-2264-z. Epub 2012 Mar 7.
• Background Cavaliere F, De Simone M, Virzi S, Deraco M, Rossi CR, Garofalo A, Di Filippo F, Giannarelli D, Vaira M, Valle M, Pilati P, Perri P, La Pinta M, Monsellato I, Guadagni F. Prognostic factors and oncologic outcome in 146 patients with colorectal peritoneal carcinomatosis treated with cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy: Italian multicenter study S.I.T.I.L.O. Eur J Surg Oncol. 2011 Feb;37(2):148-54. doi: 10.1016/j.ejso.2010.10.014. Epub 2010 Nov 18.
• Background Elias D, Lefevre JH, Chevalier J, Brouquet A, Marchal F, Classe JM, Ferron G, Guilloit JM, Meeus P, Goere D, Bonastre J. Complete cytoreductive surgery plus intraperitoneal chemohyperthermia with oxaliplatin for peritoneal carcinomatosis of colorectal origin. J Clin Oncol. 2009 Feb 10;27(5):681-5. doi: 10.1200/JCO.2008.19.7160. Epub 2008 Dec 22.
• Background Quenet F, Goere D, Mehta SS, Roca L, Dumont F, Hessissen M, Saint-Aubert B, Elias D. Results of two bi-institutional prospective studies using intraperitoneal oxaliplatin with or without irinotecan during HIPEC after cytoreductive surgery for colorectal carcinomatosis. Ann Surg. 2011 Aug;254(2):294-301. doi: 10.1097/SLA.0b013e3182263933.
• Background Franko J, Ibrahim Z, Gusani NJ, Holtzman MP, Bartlett DL, Zeh HJ 3rd. Cytoreductive surgery and hyperthermic intraperitoneal chemoperfusion versus systemic chemotherapy alone for colorectal peritoneal carcinomatosis. Cancer. 2010 Aug 15;116(16):3756-62. doi: 10.1002/cncr.25116.
• Background Cashin PH, Graf W, Nygren P, Mahteme H. Cytoreductive surgery and intraperitoneal chemotherapy for colorectal peritoneal carcinomatosis: prognosis and treatment of recurrences in a cohort study. Eur J Surg Oncol. 2012 Jun;38(6):509-15. doi: 10.1016/j.ejso.2012.03.001. Epub 2012 Apr 3.
• Background Shen P, Hawksworth J, Lovato J, Loggie BW, Geisinger KR, Fleming RA, Levine EA. Cytoreductive surgery and intraperitoneal hyperthermic chemotherapy with mitomycin C for peritoneal carcinomatosis from nonappendiceal colorectal carcinoma. Ann Surg Oncol. 2004 Feb;11(2):178-86. doi: 10.1245/aso.2004.05.009.
• Background Vaira M, Cioppa T, D'Amico S, de Marco G, D'Alessandro M, Fiorentini G, De Simone M. Treatment of peritoneal carcinomatosis from colonic cancer by cytoreduction, peritonectomy and hyperthermic intraperitoneal chemotherapy (HIPEC). Experience of ten years. In Vivo. 2010 Jan-Feb;24(1):79-84.
• Results Ceelen W, Van Nieuwenhove Y, Putte DV, Pattyn P. Neoadjuvant chemotherapy with bevacizumab may improve outcome after cytoreduction and hyperthermic intraperitoneal chemoperfusion (HIPEC) for colorectal carcinomatosis. Ann Surg Oncol. 2014 Sep;21(9):3023-8. doi: 10.1245/s10434-014-3713-7. Epub 2014 Apr 23.
• Results Tamsma JT, Keizer HJ, Meinders AE. Pathogenesis of malignant ascites: Starling's law of capillary hemodynamics revisited. Ann Oncol. 2001 Oct;12(10):1353-7. doi: 10.1023/a:1012504904713.
• Results Welch S, Spithoff K, Rumble RB, Maroun J; Gastrointestinal Cancer Disease Site Group. Bevacizumab combined with chemotherapy for patients with advanced colorectal cancer: a systematic review. Ann Oncol. 2010 Jun;21(6):1152-1162. doi: 10.1093/annonc/mdp533. Epub 2009 Nov 25.
• Results Olsen MW, Ley CD, Junker N, Hansen AJ, Lund EL, Kristjansen PE. Angiopoietin-4 inhibits angiogenesis and reduces interstitial fluid pressure. Neoplasia. 2006 May;8(5):364-72. doi: 10.1593/neo.06127.
• Results Nakahara T, Norberg SM, Shalinsky DR, Hu-Lowe DD, McDonald DM. Effect of inhibition of vascular endothelial growth factor signaling on distribution of extravasated antibodies in tumors. Cancer Res. 2006 Feb 1;66(3):1434-45. doi: 10.1158/0008-5472.CAN-05-0923.
• Results Willett CG, Boucher Y, di Tomaso E, Duda DG, Munn LL, Tong RT, Chung DC, Sahani DV, Kalva SP, Kozin SV, Mino M, Cohen KS, Scadden DT, Hartford AC, Fischman AJ, Clark JW, Ryan DP, Zhu AX, Blaszkowsky LS, Chen HX, Shellito PC, Lauwers GY, Jain RK. Direct evidence that the VEGF-specific antibody bevacizumab has antivascular effects in human rectal cancer. Nat Med. 2004 Feb;10(2):145-7. doi: 10.1038/nm988. Epub 2004 Jan 25.
• Results Kobold S, Hegewisch-Becker S, Oechsle K, Jordan K, Bokemeyer C, Atanackovic D. Intraperitoneal VEGF inhibition using bevacizumab: a potential approach for the symptomatic treatment of malignant ascites? Oncologist. 2009 Dec;14(12):1242-51. doi: 10.1634/theoncologist.2009-0109. Epub 2009 Dec 11.
• Willaert W, Van Der Speeten K, Liberale G, Ceelen W. BEV-IP: Perioperative chemotherapy with bevacizumab in patients undergoing cytoreduction and intraperitoneal chemoperfusion for colorectal carcinomatosis. BMC Cancer. 2015 Dec 16;15:980. doi: 10.1186/s12885-015-1954-x.

Drugs

Indications