A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: A gynecologic oncology group study

Gynecologic Oncology

Volumn 125, Issue 2, 2012, Pages 367-371

  Dizon, Don S ^a   Blessing, John A ^b   Penson, Richard T ^c   Drake, Richard D ^d   Walker, Joan L ^e   Johnston, Carolyn M ^f   Disilvestro, Paul A ^a   Fader, Amanda Nickles ^g  

^a BROWN UNIVERSITY   (United States)

^b ROSWELL PARK CANCER INSTITUTE   (United States)

^c MASSACHUSETTS GENERAL HOSPITAL   (United States)

^d TAUSSIG CANCER INSTITUTE   (United States)

^e UNIVERSITY OF OKLAHOMA   (United States)

^f UNIVERSITY OF MICHIGAN   (United States)

^g GREATER BALTIMORE MEDICAL CENTER   (United States)

Author keywords

Carboplatin; Chemotherapy; HIDAC inhibitors; Ovarian cancer; Platinum resistant

Indexed keywords

BELINOSTAT; CARBOPLATIN;

ADULT; AGED; ANEMIA; ARTICLE; BLEEDING DISORDER; CANCER COMBINATION CHEMOTHERAPY; CANCER RECURRENCE; CANCER SURVIVAL; CARCINOMATOUS PERITONITIS; CARDIOVASCULAR DISEASE; DRUG DOSE REDUCTION; DRUG HYPERSENSITIVITY; DRUG SCREENING; ENDOCRINE DISEASE; FEMALE; GASTROINTESTINAL DISEASE; GYNECOLOGIC CARE; HUMAN; LEUKOPENIA; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL DISEASE; NAUSEA; NEUTROPENIA; OVARY CARCINOMA; OVERALL SURVIVAL; PERITONEUM CANCER; PHASE 2 CLINICAL TRIAL; PRIMARY PERITONEAL CARCINOMA; PRIMARY TUMOR; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; SKIN DISEASE; THROMBOCYTOPENIA; TREATMENT RESPONSE; UROGENITAL TRACT DISEASE; UTERINE TUBE; UTERINE TUBE CARCINOMA;

AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CARBOPLATIN; DISEASE-FREE SURVIVAL; DRUG RESISTANCE, NEOPLASM; FALLOPIAN TUBE NEOPLASMS; FEMALE; HUMANS; HYDROXAMIC ACIDS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; OVARIAN NEOPLASMS; PERITONEAL NEOPLASMS;

EID: 84863419977     PISSN: 00908258     EISSN: 10956859     Source Type: Journal    
DOI: 10.1016/j.ygyno.2012.02.019     Document Type: Article

References (20)

1. American Cancer Society Cancer Facts & Figures 2010. (2010).
2. Parmar MK, Ledermann JA, Colombo N, du Bois A, Delaloye JF, Kristensen GB, et al. Paclitaxel plus platinum-based chemotherapy versus conventional platinum-based chemotherapy in women with relapsed ovarian cancer: the ICON4/AGOOVAR- 2.2 trial. Lancet 2003;361:2099-106.
3. Pfisterer J, Plante M, Vergote I, du Bois A, Hirte H, Lacave AJ, et al. 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 2006;24:4699-707. (Pubitemid 46630933)
4. Pujade-Lauraine E, Wagner U, Aavall-Lundquist E, Gebski V, Heywood M, Vasey PA, et al. Pegylated liposomal Doxorubicin and Carboplatin compared with Paclitaxel and Carboplatin for patients with platinum-sensitive ovarian cancer in late relapse. J Clin Oncol 2010;28:3323-39.
5. Brewer CA, Blessing JA, Nagourney RA, Morgan M, Hanjani P. Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol 2006;103:446-50. (Pubitemid 44602150)
6. Rasheed WK, Johnstone RW, Prince HM. Histone deacetylase inhibitors in cancer therapy. Expert Opin Investig Drugs 2007;16:659-78. (Pubitemid 46729100)
7. Qian X, LaRochelle WJ, Ara G, Wu F, Petersen KD, Thougaard A, et al. Activity of PXD101, a histone deacetylase inhibitor, in preclinical ovarian cancer studies. Mol Cancer Ther 2006;5:2086-95. (Pubitemid 44336581)
8. MackayHJ, HirteH, Colgan T, CovensA,MacAlpine K, Grenci P, et al. Phase II trial of the histone deacetylase inhibitor Belinostat in women with platinum resistant epithelial ovarian cancer and micropapillary (LMP) ovarian tumors. Eur J Cancer 2010;46:1573-9.
9. Giaccone G, Rajan A, Berman A, Kelly RJ, Szabo E, Lopez-Chavez A, et al. Phase II Study of Belinostat in Patients With Recurrent or Refractory Advanced Thymic Epithelial Tumors. J Clin Oncol 2011;29:2052-9.
10. Ramalingam SS, Belani CP, Ruel C, Frankel P, Gitlitz B, Koczywas M, et al. Phase II study of Belinostat (PXD101), a histone deacetylase inhibitor, for second line therapy of advanced malignant pleural mesothelioma. J Thorac Oncol 2009;4:97-101.
11. Lassen U, Molife LR, Sorensen M, Engelholm SA, Vidal L, Sinha R, et al. A phase I study of the safety and pharmacokinetics of the histone deacetylase inhibitor belinostat administered in combination with carboplatin and/or paclitaxel in patients with solid tumours. Br J Cancer 2010;103:12-7.
12. Finkler NJ, Dizon DS, Braly P, Micha J, Lassen U, Celano P, et al. Phase II multicenter trial of the histone deactylase inhibitor (HDACi) belinostat, carboplatin and paclitaxel (BelCaP) in patients (pts) with relapsed epithelial ovarian cancer (EOC). J Clin Oncol 2008;26:15 [abstr 5519].
13. Eisenhauer EA. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-47.
14. Rustin GJ, Quinn M, Thigpen T, du Bois A, Pujade-Lauraine E, Jakobsen A, et al. Re: New guidelines to evaluate the response to treatment in solid tumors (ovarian cancer). J Natl Cancer Inst 2004;96:487-8. (Pubitemid 38443654)
15. Chen TT, Ng TH. Optimal flexible designs in phase II clinical trials. Stat Med 1998;17:2301-12. (Pubitemid 28482675)
16. Graham JS, Kaye SB, Brown R. The promises and pitfalls of epigenetic therapies in solid tumours. Eur J Cancer 2009;45:1129-36.
17. Weichert W, Denkert C, Noske A, Darb-Esfahani S, Dietel M, Kalloger SE, et al. Expression of class I histone deacetylases indicates poor prognosis in endometrioid subtypes of ovarian and endometrial carcinomas. Neoplasia 2008;10:1021-7.
18. Burger RA, Sill MW, Monk BJ, Greer BE, Sorosky JI. Phase II trial of bevacizumab in persistent or recurrent epithelial ovarian cancer or primary peritoneal cancer: a Gynecologic Oncology Group Study. J Clin Oncol 2007;25:5165-71. (Pubitemid 350237599)
19. Cannistra SA. Phase II trials in Journal of ClinicalOncology. J ClinOncol 2009;27:3073-6.
20. Yardley DA, Ismail-Khan R, Klein P. Results of ENCORE 301, a randomized, phase II, double-blind, placebo-controlled study of exemestane with or without entinostat in postmenopausal women with locally recurrent or metastatic estrogen receptor-positive (ER+) breast cancer progressing on a nonsteroidal aromatase inhibitor (AI). J Clin Oncol 2011;29 [abstr 268].