Open-label feasibility study of pazopanib, carboplatin, and paclitaxel in women with newly diagnosed, untreated, gynaecologic tumours: A phase I/II trial of the AGO study group

British Journal of Cancer

Volumn 106, Issue 4, 2012, Pages 629-632

  Du Bois, A ^a   Vergote, I ^b   Wimberger, P ^c   Ray Coquard, I ^d   Harter, P ^a   Curtis, L B ^e   Mitrica, I ^f  

^a KLINIKEN ESSEN MITTE   (Germany)

^b UNIVERSITY HOSPITALS LEUVEN   (Belgium)

^c UNIVERSITY OF DUISBURG ESSEN   (Germany)

^d CENTRE LÉON BÉRARD   (France)

^e GLAXOSMITHKLINE   (United Kingdom)

^f GLAXOSMITHKLINE   (United States)

Author keywords

ovarian cancer; pazopanib; phase I study

Indexed keywords

CARBOPLATIN; PACLITAXEL; PAZOPANIB;

ABDOMINAL PAIN; ADULT; AGED; ALOPECIA; AREA UNDER THE CURVE; ARTICLE; CANCER FATIGUE; CHEMOTHERAPY INDUCED EMESIS; CLINICAL ARTICLE; DIARRHEA; DIGESTIVE SYSTEM PERFORATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FEMALE GENITAL TRACT TUMOR; HUMAN; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RHINOPHARYNGITIS; SIDE EFFECT; THROMBOCYTOPENIA; VOMITING;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; EARLY TERMINATION OF CLINICAL TRIALS; FEASIBILITY STUDIES; FEMALE; GENITAL NEOPLASMS, FEMALE; HUMANS; MIDDLE AGED; PACLITAXEL; PYRIMIDINES; SULFONAMIDES;

EID: 84856897823     PISSN: 00070920     EISSN: 15321827     Source Type: Journal    
DOI: 10.1038/bjc.2011.608     Document Type: Article

References (24)

1. Altorki N, Lane ME, Bauer T, Lee PC, Guarino MJ, Pass H, Felip E, Peylan-Ramu N, Gurpide A, Grannis FW, Mitchell JD, Tachdjian S, Swann RS, Huff A, Roychowdhury DF, Reeves A, Ottesen LH, Yankelevitz DF (2010) Phase II proof-of-concept study of pazopanib monotherapy in treatment-naive patients with stage I/II resectable non-small-cell lung cancer. J Clin Oncol 28(19): 3131-3137
2. Burger RA, Brady MF, Bookman MA, Walker JL, Homesley HD, Fowler J, Monk BJ, Greer BE, Boente M, Liang SX (2010) Phase III trial of bevacizumab (BEV) in the primary treatment of advanced epithelial ovarian cancer (EOC), primary peritoneal cancer (PPC), or fallopian tube cancer (FTC): A Gynecologic Oncology Group study. J Clin Oncol 28(18s): 18s, (abstract LBA1)
3. Burris H, Du Bois A, Dowlati A, Gainer S, Park J, Stutts M, Dar M, Suttle B, Mitrica I, Tan AR (2009) Pazopanib combination with paclitaxel and carboplatin in patients with advanced solid tumors and gynecological cancers: Results of two phase I studies. Mol Cancer Ther 8(12): (abstract A6)
4. Cooper BC, Ritchie JM, Broghammer CL, Coffin J, Sorosky JI, Buller RE, Hendrix MJ, Sood AK (2002) Preoperative serum vascular endothelial growth factor levels: Significance in ovarian cancer. Clin Cancer Res 8(10): 3193-3197 (Pubitemid 35155030)
5. du Bois A, Luck HJ, Meier W, Adams HP, Mobus V, Costa S, Bauknecht T, Richter B, Warm M, Schroder W, Olbricht S, Nitz U, Jackisch C, Emons G, Wagner U, Kuhn W, Pfisterer J (2003) A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer. J Natl Cancer Inst 95(17): 1320-1329
6. Friedlander M, Hancock KC, Rischin D, Messing MJ, Stringer CA, Matthys GM, Ma B, Hodge JP, Lager JJ (2010) A Phase II, open-label study evaluating pazopanib in patients with recurrent ovarian cancer. Gynecol Oncol 119(1): 32-37
7. Greer BE, Koh WJ, Abu-Rustum N, Bookman MA, Bristow RE, Campos S, Cho KR, Copeland L, Eifel P, Huh WK, Jaggernauth W, Kapp DS, Kavanagh J, Lipscomb GH, Lurain III JR, Morgan M, Morgan Jr RJ, Powell CB, Remmenga SW, Reynolds RK, Secord AA, Small Jr W, Teng N (2008) Cervical cancer. J Natl Compr Canc Netw 6(1): 14-36 (Pubitemid 351212000)
8. Harter P, Marth C (2011) Gynecologic Cancer Intergroup Ovarian Cancer Committee report [slide presentation]. Presented at: GCIG Autumn Meeting; 8-9 September 2011; Milan, Italy. Available at: Http:// www.gcig.igcs.org/files/ OvarianGAReport(1).ppt (accessed 19 September 2011)
9. Heath EI, Blumenschein Jr GR, Cohen RB, Lorusso PM, Loconte NK, Kim ST, Ruiz-Garcia A, Chao RC, Wilding G (2011) Sunitinib in combination with paclitaxel plus carboplatin in patients with advanced solid tumors: Phase I study results. Cancer Chemother Pharmacol 68(3): 703-712
10. Hurwitz HI, Dowlati A, Saini S, Savage S, Suttle AB, Gibson DM, Hodge JP, Merkle EM, Pandite L (2009) Phase I trial of pazopanib in patients with advanced cancer. Clin Cancer Res 15(12): 4220-4227
11. Iwamoto FM, Lamborn KR, Robins HI, Mehta MP, Chang SM, Butowski NA, Deangelis LM, Abrey LE, Zhang WT, Prados MD, Fine HA (2010) Phase II trial of pazopanib (GW786034), an oral multi-targeted angiogenesis inhibitor, for adults with recurrent glioblastoma (North American Brain Tumor Consortium Study 06-02). Neuro Oncol 12(8): 855-861
12. Kristensen G, Perren T, Qian W, Pfisterer J, Ledermann JA, Joly F, Carey MS, Beale PJ, Cervantes A, Oza AM, GCIG (2011) Result of interim analysis of overall survival in the GCIG ICON7 phase III randomized trial of bevacizumab in women with newly diagnosed ovarian cancer. J Clin Oncol 29(Suppl): (abstract LBA5006)
13. Monk BJ, Mas Lopez L, Zarba JJ, Oaknin A, Tarpin C, Termrungruanglert W, Alber JA, Ding J, Stutts MW, Pandite LN (2010) Phase II, open-label study of pazopanib or lapatinib monotherapy compared with pazopanib plus lapatinib combination therapy in patients with advanced and recurrent cervical cancer. J Clin Oncol 28(22): 3562-3569
14. Morgan Jr RJ, Alvarez RD, Armstrong DK, Boston B, Chen LM, Copeland L, Fowler J, Gaffney DK, Gershenson D, Greer BE, Grigsby PW, Havrilesky LJ, Johnston C, Lancaster JM, Lele S, Matulonis U, O'Malley D, Ozols RF, Remmenga SW, Sabbatini P, Schink J, Teng N (2008) Ovarian cancer. Clinical practice guidelines in oncology. J Natl Compr Canc Netw 6(8): 766-794
15. National Cancer Institute (2011) Pazopanib hydrochloride, paclitaxel, and carboplatin in treating patients with refractory or resistant ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer. Available at: Http://clinicaltrials.gov/ct2/show/NCT01402271?term=EORTC+55092&rank=1 (Accessed on 19 September 2011)
16. Polcher M, Eckhardt M, Coch C, Wolfgarten M, Kubler K, Hartmann G, Kuhn W, Rudlowski C (2010) Sorafenib in combination with carboplatin and paclitaxel as neoadjuvant chemotherapy in patients with advanced ovarian cancer. Cancer Chemother Pharmacol 66(1): 203-207
17. Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C (2009) Phase III trial of cisplatin plus gemcitabine with either placebo or bevacizumab as first-line therapy for nonsquamous non-small-cell lung cancer: AVAil. J Clin Oncol 27(8): 1227-1234
18. Sandler A, Gray R, Perry MC, Brahmer J, Schiller JH, Dowlati A, Lilenbaum R, Johnson DH (2006) Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med 355(24): 2542-2550 (Pubitemid 44917502)
19. Sleijfer S, Ray-Coquard I, Papai Z, Le Cesne A, Scurr M, Schoffski P, Collin F, Pandite L, Marreaud S, De Brauwer A, van Glabbeke M, Verweij J, Blay JY (2009) Pazopanib, a multikinase angiogenesis inhibitor, in patients with relapsed or refractory advanced soft tissue sarcoma: A phase II study from the European organisation for research and treatment of cancersoft tissue and bone sarcoma group (EORTC study 62043). J Clin Oncol 27(19): 3126-3132
20. Sonpavde G, Hutson TE (2007) Pazopanib: A novel multitargeted tyrosine kinase inhibitor. Curr Oncol Rep 9(2): 115-119 (Pubitemid 46332383)
21. Sternberg CN, Davis ID, Mardiak J, Szczylik C, Lee E, Wagstaff J, Barrios CH, Salman P, Gladkov OA, Kavina A, Zarba JJ, Chen M, McCann L, Pandite L, Roychowdhury DF, Hawkins RE (2010) Pazopanib in locally advanced or metastatic renal cell carcinoma: Results of a randomized phase III trial. J Clin Oncol 28(6): 1061-1068
22. Taylor SK, Chia S, Dent S, Clemons M, Agulnik M, Grenci P, Wang L, Oza AM, Ivy P, Pritchard KI, Leighl NB (2010) A phase II study of pazopanib in patients with recurrent or metastatic invasive breast carcinoma: A trial of the Princess Margaret Hospital phase II consortium. Oncologist 15(8): 810-818
23. Van Der Graaf WT, Blay J, Chawla SP, Kim D, Bui Nguyen B, Casali PG, Schöffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji M, Dei Tos AP, Hohenberger P (2011) PALETTE: A randomized, double-blind, phase III trial of pazopanib versus placebo in patients (pts) with soft-tissue sarcoma (STS) whose disease has progressed during or following prior chemotherapy-An EORTC STBSG Global Network Study (EORTC 62072). J Clin Oncol 29(suppl): (abstract LBA10002)
24. Yamamoto S, Konishi I, Mandai M, Kuroda H, Komatsu T, Nanbu K, Sakahara H, Mori T (1997) Expression of vascular endothelial growth factor (VEGF) in epithelial ovarian neoplasms: Correlation with clinicopathology and patient survival, and analysis of serum VEGF levels. Br J Cancer 76(9): 1221-1227 (Pubitemid 27448021)