A phase II clinical trial of pegylated liposomal doxorubicin and carboplatin plus bevacizumab in patients with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer

Gynecologic Oncology

Volumn 126, Issue 3, 2012, Pages 369-374

  Del Carmen, Marcela G ^a   Micha, John ^b   Small, Laurie ^c   Street, Daron G ^d   Londhe, Anil ^e   McGowan, Tracy ^f  

^a MASSACHUSETTS GENERAL HOSPITAL   (United States)

^b Gynecologic Oncology Associates   (United States)

^c MAINE MEDICAL CENTER   (United States)

^d Cancer Care Associates   (United States)

^e JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

^f Janssen Services LLC   (United States)

Author keywords

Bevacizumab; Carboplatin; Fallopian tube cancer; Ovarian cancer; Pegylated liposomal doxorubicin; Primary peritoneal cancer

Indexed keywords

BEVACIZUMAB; CARBOPLATIN; DOXORUBICIN;

ABDOMINAL ABSCESS; ACUTE KIDNEY FAILURE; ADULT; AGED; APHTHOUS STOMATITIS; BLOOD PRESSURE; CANCER COMBINATION CHEMOTHERAPY; CANCER GROWTH; CANCER RECURRENCE; CHEMOTHERAPY INDUCED ANEMIA; CHRONIC OBSTRUCTIVE LUNG DISEASE; CONFERENCE PAPER; DEEP VEIN THROMBOSIS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; EPISTAXIS; FATIGUE; FEMALE; HAND FOOT SYNDROME; HUMAN; HYPERTENSION; INTESTINE OBSTRUCTION; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OVARY CANCER; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; PROTEINURIA; SIDE EFFECT; SMALL INTESTINE PERFORATION; STOMATITIS; THROMBOCYTOPENIA; TIME TO PROGRESSION; TREATMENT OUTCOME; TREATMENT WITHDRAWAL; UTERINE TUBE CARCINOMA;

ABDOMINAL ABSCESS; AGED; AGED, 80 AND OVER; ANEMIA; ANTIBODIES, MONOCLONAL, HUMANIZED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; AREA UNDER CURVE; CARBOPLATIN; CARCINOMA; CONFIDENCE INTERVALS; DISEASE PROGRESSION; DISEASE-FREE SURVIVAL; DOXORUBICIN; FALLOPIAN TUBE NEOPLASMS; FEMALE; HAND-FOOT SYNDROME; HUMANS; HYPERTENSION; INTENTION TO TREAT ANALYSIS; INTESTINAL OBSTRUCTION; INTESTINAL PERFORATION; KAPLAN-MEIER ESTIMATE; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; NEOPLASMS, GLANDULAR AND EPITHELIAL; NEUTROPENIA; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS; POLYETHYLENE GLYCOLS; PROTEINURIA; STOMATITIS; STROKE VOLUME; THROMBOCYTOPENIA; TIME FACTORS;

EID: 84864396971     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2012.05.028     Document Type: Conference Paper

References (24)

1. American Cancer Society, Inc. Cancer Facts & Figures 2010. http://www.cancer.org/acs/groups/content/@nho/documents/document/acspc-024113. pdf. Atlanta, GA: American Cancer Society, Inc; 2010.
2. W.P. McGuire, W.J. Hoskins, M.F. Brady, P.R. Kucera, E.E. Partridge, and K.Y. Look Cyclophosphamide and cisplatin compared with paclitaxel and cisplatin in patients with stage III and stage IV ovarian cancer N Engl J Med 334 1996 1 6 (Pubitemid 26012496)
3. R.F. Ozols, B.N. Bundy, B.E. Greer, J.M. Fowler, D. Clarke-Pearson, and R.A. Burger Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study J Clin Oncol 21 2003 3194 3200 (Pubitemid 46606249)
4. J.D. Wright, A.A. Secord, T.M. Numnum, R.P. Rocconi, M.A. Powell, and A. Berchuck A multi-institutional evaluation of factors predictive of toxicity and efficacy of bevacizumab for recurrent ovarian cancer Int J Gynecol Cancer 18 2008 400 406 (Pubitemid 351668295)
5. A. du Bois, H.J. Lück, W. Meier, H.P. Adams, V. Möbus, and S. Costa; for the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) Ovarian Cancer Study Group. A randomized clinical trial of cisplatin/paclitaxel versus carboplatin/paclitaxel as first-line treatment of ovarian cancer J Natl Cancer Inst 95 2003 1320 1329
6. G.C. Stuart, H. Kitchener, M. Bacon, A. duBois, M. Friedlander, and J. Ledermann 2010 Gynecologic Cancer InterGroup (GCIG) consensus statement on clinical trials in ovarian cancer: report from the Fourth Ovarian Cancer Consensus Conference Int J Gynecol Cancer 21 2011 750 755
7. A.J. González-Martín, E. Calvo, I. Bover, M.J. Rubio, A. Arcusa, and A. Casado Randomized phase II trial of carboplatin versus paclitaxel and carboplatin in platinum-sensitive recurrent advanced ovarian carcinoma: a GEICO (Grupo Español de Investigación en Cáncer de Ovario) study Ann Oncol 16 2005 749 755 (Pubitemid 40767095)
8. M.K. Parmar, J.A. Ledermann, N. Colombo, A. du Bois, J.F. Delaloye, and G.B. Kristensen; ICON and AGO Collaborators. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGO-OVAR-2.2 trial Lancet 361 2003 2099 2106
9. J. Pfisterer, M. Plante, I. Vergote, A. du Bois, H. Hirte, and A.J. Lacave Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG J Clin Oncol 24 2006 4699 4707 (Pubitemid 46630933)
10. R.A. Burger, M.W. Sill, B.J. Monk, B.E. Greer, and J.I. Sorosky Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group study J Clin Oncol 25 2007 5165 5171 (Pubitemid 350237599)
11. A.N. Gordon, J.T. Fleagle, D. Guthrie, D.E. Parkin, M.E. Gore, and A.J. Lacave Recurrent epithelial ovarian carcinoma: a randomized phase III study of pegylated liposomal doxorubicin versus topotecan J Clin Oncol 19 2001 3312 3322 (Pubitemid 32642183)
12. A. du Bois, J. Pfisterer, N. Burchardi, S. Loibl, J. Huober, and P. Wimberger Combination therapy with pegylated liposomal doxorubicin and carboplatin in gynecologic malignancies: a prospective phase II study of the Arbeitsgemeinschaft Gynäekologische Onkologie Studiengruppe Ovarialkarzinom (AGO-OVAR) and Kommission Uterus (AGO-K-Ut) Gynecol Oncol 107 2007 518 525 (Pubitemid 350160867)
13. J.M. Ferrero, B. Weber, J.F. Geay, D. Lepille, H. Orfeuvre, and M. Combe Second-line chemotherapy with pegylated liposomal doxorubicin and carboplatin is highly effective in patients with advanced ovarian cancer in late relapse: a GINECO phase II trial Ann Oncol 18 2007 263 268 (Pubitemid 46323091)
14. D.S. Alberts, P.Y. Liu, S.P. Wilczynski, M.C. Clouser, A.M. Lopez, and D.P. Michelin Randomized trial of pegylated liposomal doxorubicin (PLD) plus carboplatin versus carboplatin in platinum-sensitive (PS) patients with recurrent epithelial ovarian or peritoneal carcinoma after failure of initial platinum-based chemotherapy (Southwest Oncology Group Protocol S0200) Gynecol Oncol 108 2008 90 94 (Pubitemid 350299426)
15. E. Pujade-Lauraine, U. Wagner, E. Aavall-Lundqvist, V. Gebski, M. Heywood, and P.A. Vasey Pegylated liposomal doxorubicin and carboplatin compared with paclitaxel and carboplatin for patients with platinum-sensitive ovarian cancer in late relapse J Clin Oncol 28 2010 3323 3329
16. AVASTIN® (bevacizumab) [full prescribing information]. Inc. San Francisco, CA: Genentech, Inc; Revised December 2011.
17. S.A. Cannistra, U.A. Matulonis, R.T. Penson, J. Hambleton, J. Dupont, and H. Mackey Phase II study of bevacizumab in patients with platinum-resistant ovarian cancer or peritoneal serous cancer J Clin Oncol 25 2007 5180 5186 (Pubitemid 350232248)
18. A.A. Garcia, H. Hirte, G. Fleming, D. Yang, D.D. Tsao-Wei, and L. Roman Phase II clinical trial of bevacizumab and low-dose metronomic oral cyclophosphamide in recurrent ovarian cancer: a trial of the California, Chicago, and Princess Margaret Hospital phase II consortia J Clin Oncol 26 2008 76 82
19. H.S. Nimeiri, A.M. Oza, R.J. Morgan, G. Friberg, K. Kasza, and L. Faoro Efficacy and safety of bevacizumab plus erlotinib for patients with recurrent ovarian, primary peritoneal, and fallopian tube cancer: a trial of the Chicago, PMH, and California Phase II Consortia Gynecol Oncol 110 2008 49 55
20. Carboplatin monograph S.E. McEvoy GK, and J. Miller Published by the American Society of Health-System Pharmacists American Hospital Formulary Service 2011 AHFS Drug Information Bethesda, MD
21. DOXIL® (doxorubicin HCl liposome injection) [full prescribing information] March 2011 Bedford, OH: Ben Venue Laboratories, Inc; Revised March 2011
22. C. Aghajanian, N.J. Finkler, T. Rutherford, T. Rutherford, M.G. Teneriello, J. Yi, and H. Parmar OCEANS: a randomized, double-blinded, placebo-controlled phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC) Proceedings of the American Society of Clinical Oncology (ASCO) Annual Meeting; June 3-7, 2011; Chicago, IL 2011 LBA5007
23. S. Pignata, G. Scambia, G. Ferrandina, A. Savarese, R. Sorio, and E. Breda Carboplatin plus paclitaxel versus carboplatin plus pegylated liposomal doxorubicin as first-line treatment for patients with ovarian cancer: the MITO-2 randomized phase III trial J Clin Oncol 29 2011 3628 3635
24. R.A. Burger, M.F. Brady, M.A. Bookman, G.F. Fleming, B.J. Monk, and H. Huang for the Gynecologic Oncology Group. Incorporation of bevacizumab in the primary treatment of ovarian cancer N Engl J Med 365 2011 2473 2483