Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
Information source: Yale University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Endometrial Cancer
Intervention: Carboplatin/Paclitaxel (Drug); Trastuzumab (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Yale University Official(s) and/or principal investigator(s): Alessandro D Santin, M.D., Principal Investigator, Affiliation: Yale University
Overall contact: Alessandro D Santin, M.D., Phone: 203-737-4450, Email: alessandro.santin@yale.edu
Summary
The primary objective of this study is to estimate whether the addition of trastuzumab to
paclitaxel and carboplatin chemotherapy improves progression free survival when compared to
paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients
overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence
in situ hybridization (FISH).
Clinical Details
Official title: Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in HER2/Neu+ Patients With Advance/Recurrent Uterine Serous Papillary Carcinoma
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Progression free survival differences between Arm A versus Arm B.
Secondary outcome: To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0
Detailed description:
The purpose of this study is to perform a randomized Phase II evaluation of
Carboplatin/Paclitaxel with or without Trastuzumab (Herceptin) in patients with HER2/neu+
advanced stage/recurrent disease with an emphasis on determining the progression free
survival in USPC patients and assessing immunologic markers predictive of trastuzumab
response.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC
with measurable disease.
- Patients must harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with
confirmed gene amplification by FISH
Exclusion Criteria:
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancers, significant history of cardiac disease, uncontrolled
hypertension, unstable medical issue, brain leptomeningeal, prior therapy with
trastuzumab, uncontrolled seizure disorder, seropositive for HIV, active hepatitis,
hemorrhagic diathesis or requiring supplemental oxygen.
Locations and Contacts
Alessandro D Santin, M.D., Phone: 203-737-4450, Email: alessandro.santin@yale.edu
St. Joseph's Hospital and Medical Center, Pheonix, Arizona 85013, United States; Recruiting Dana Chase, M.D., Phone: 602-406-7730, Email: dana.chase@dignityhealth.org Kelli Williamson, RN, MPH, Phone: 602-406-689, Email: kelli.williamson@dignityhealth.org Dana Chase, M.D., Principal Investigator
University of Arizona Cancer Center, Tucson, Arizona 85704, United States; Recruiting Setsuko Chambers, M.D., Phone: 520-626-9283, Email: schambers@uacc.arizona.edu Katherine Center, Phone: 520-626-9283, Email: kcenter@uacc.arizona.edu Setsuko Chambers, M.D., Principal Investigator
University of Arizona Cancer Center, Tucson, Arizona 85724, United States; Recruiting Setsuko Chambers, M.D., Phone: 520-626-0950, Email: schambers@uacc.arizona.edu Katherine Center, Phone: 520-626-9283, Email: kcenter@uacc.arizona.edu Setsuko Chambers, M.D., Principal Investigator
John Muir Clinical Research Center, Concord, California 94520, United States; Recruiting Babak Edraki, M.D., Phone: 925-674-2580, Email: babak.edraki@johnmuirhealth.com Peggy Newsom, Phone: 925-674-2198, Email: peggy.newsom@johhmuirhealth.com Babak Edraki, M.D., Principal Investigator
University of California at Los Angeles, Los Angeles, California 90095, United States; Not yet recruiting Gottfried Konecny, M.D., Phone: 310-586-2652, Email: gkonecny@mednet.ucla.edu Christy Palodichuk Gottfried Konecny, M.D., Principal Investigator
Penrose St. Francis Hospital, Colorado Springs, Colorado 80907, United States; Recruiting Dirk Pikkaart, M.D., Phone: 719-776-6222, Email: pikaartdp@gmail.com Cynthia Winemiller, Phone: 719-776-6222, Email: cynthiawinemiller@centura.org Dirk Pikkaart, M.D., Principal Investigator
The Hospital of Central Connecticut, New Britain, Connecticut 06050, United States; Recruiting James Hoffman, M.D., Phone: 860-826-1101, Email: james.hoffman@hhchealth.org Siobhan Reilly, CCRP, Phone: 860-224-5900, Ext: 6718, Email: siobhan.reilly@hhchealth.org James Hoffman, M.D., Sub-Investigator
Smilow Cancer Hospital at Yale New Haven, New Haven, Connecticut 06510, United States; Recruiting Alessandro D Santin, M.D., Phone: 203-737-4450, Email: alessandro.santin@yale.edu Martha Luther, R.N., Phone: 203-737-2781, Email: martha.luther@yale.edu Alessandro Santin, M.D., Principal Investigator
The University of Chicago Medicine, Chicago, Illinois 60637, United States; Recruiting Gini Fleming, M.D., Phone: 773-702-6712, Email: gfleming@medicine.bsd.uchicago.edu Tiffany Parks, BS, CRA, Phone: 773-834-2643, Email: tparks@bsd.uchicago.edu Gini Fleming, M.D., Principal Investigator
Greater Baltimore Medical Center, Baltimore, Maryland 21204, United States; Recruiting Amanda Nickles-Fader, M.D., Phone: 443-803-0235, Email: amandafader@gmail.com Tahisa Hamwright, B.S., Phone: 443-849-3123, Email: thamwright@gbmc.org Amanda Nickles-Fader, M.D., Principal Investigator
Walter Reed National Military Medical Center, Bethesda, Maryland 20889-5600, United States; Recruiting William J. Lowery, M.D., Phone: 301-400-1271, Email: william.lowery@med.navy.mil Jannette McIntosh, Phone: 301-400-1301, Email: jannette.j.mcintosh.civ@health.mil William J. Lowery, M.D., Principal Investigator
Holy Cross Hospital, Silver Springs, Maryland 20910, United States; Not yet recruiting Cheryl Aylesworth, M.D., Phone: 301-754-7552, Email: cheryl.aylesworth@gmail.com Lyudmila Kalnitskaya, Phone: 301-754-7552, Email: kalnitsl@holycrosshealth.org Cheryl Aylesworth, M.D., Principal Investigator
University of Maryland Medical Center, Silver Spring, Maryland 20910, United States; Recruiting Dana Roque, M.D., Phone: 301-754-7552, Email: droque@fpi.umaryland.edu Carolyn Harris, B.A., Phone: 410-328-8198, Email: charris@umm.edu Dana Roque, M.D., Principal Investigator
Jersey Shore University Medical Center, Neptune, New Jersey 07753, United States; Recruiting Karim El-Sahwi, M.D., Phone: 732-776-3790, Email: kelsahwi@meridianhealth.com Diane Russomanno, Phone: 732-776-3790, Email: drussomanno@meridianhealth.com Karim El-Sahwi, M.D., Principal Investigator
Montefiore Medical Center, Bronx, New York 10461, United States; Recruiting June Hou, M.D., Phone: 718-405-8082, Email: yhou@montefiore.org Randy Teeter, Phone: 718-405-8395, Email: rteeter@montefiore.org June Hou, M.D., Principal Investigator
Duke University School of Medicine, Durham, North Carolina 27710, United States; Recruiting Laura J. Havrilesky, M.D., Phone: 919-684-3765, Email: laura.havrilesky@duke.edu Sonja G. Hunter, AAS, Phone: 919-684-9074, Email: sonja.hunter@duke.edu Laura J Havrilesky, M.D., Principal Investigator
The Ohio State University, Hilliard, Ohio 43026, United States; Recruiting David O'Malley, M.D., Phone: 614-293-7642, Email: david.o'malley@osumc.edu Michele Vaughan, B.S., Phone: 614-366-9088, Email: michele.vaughan@osumc.edu David O'Malley, M.D., Principal Investigator
Additional Information
Related publications: Santin AD, Bellone S, Gokden M, Palmieri M, Dunn D, Agha J, Roman JJ, Hutchins L, Pecorelli S, O'Brien T, Cannon MJ, Parham GP. Overexpression of HER-2/neu in uterine serous papillary cancer. Clin Cancer Res. 2002 May;8(5):1271-9. Santin AD, Bellone S, Siegel ER, Palmieri M, Thomas M, Cannon MJ, Kay HH, Roman JJ, Burnett A, Pecorelli S. Racial differences in the overexpression of epidermal growth factor type II receptor (HER2/neu): a major prognostic indicator in uterine serous papillary cancer. Am J Obstet Gynecol. 2005 Mar;192(3):813-8. Santin AD, Bellone S, Van Stedum S, Bushen W, De Las Casas LE, Korourian S, Tian E, Roman JJ, Burnett A, Pecorelli S. Determination of HER2/neu status in uterine serous papillary carcinoma: Comparative analysis of immunohistochemistry and fluorescence in situ hybridization. Gynecol Oncol. 2005 Jul;98(1):24-30. Santin AD. Letter to the Editor referring to the manuscript entitled: "Phase II trial of trastuzumab in women with advanced or recurrent HER-positive endometrial carcinoma: a Gynecologic Oncology Group study" recently reported by Fleming et al., (Gynecol Oncol., 116;15-20;2010). Gynecol Oncol. 2010 Jul;118(1):95-6; author reply 96-7. doi: 10.1016/j.ygyno.2010.01.043. Epub 2010 Feb 20. Schwartz PE. The management of serous papillary uterine cancer. Curr Opin Oncol. 2006 Sep;18(5):494-9. Review. Cirisano FD Jr, Robboy SJ, Dodge RK, Bentley RC, Krigman HR, Synan IS, Soper JT, Clarke-Pearson DL. The outcome of stage I-II clinically and surgically staged papillary serous and clear cell endometrial cancers when compared with endometrioid carcinoma. Gynecol Oncol. 2000 Apr;77(1):55-65. Goff BA, Kato D, Schmidt RA, Ek M, Ferry JA, Muntz HG, Cain JM, Tamimi HK, Figge DC, Greer BE. Uterine papillary serous carcinoma: patterns of metastatic spread. Gynecol Oncol. 1994 Sep;54(3):264-8. Randall ME, Filiaci VL, Muss H, Spirtos NM, Mannel RS, Fowler J, Thigpen JT, Benda JA; Gynecologic Oncology Group Study. Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2006 Jan 1;24(1):36-44. Epub 2005 Dec 5. Burke TW, Gershenson DM, Morris M, Stringer CA, Levenback C, Tortolero-Luna G, Baker VV. Postoperative adjuvant cisplatin, doxorubicin, and cyclophosphamide (PAC) chemotherapy in women with high-risk endometrial carcinoma. Gynecol Oncol. 1994 Oct;55(1):47-50. Levenback C, Burke TW, Silva E, Morris M, Gershenson DM, Kavanagh JJ, Wharton JT. Uterine papillary serous carcinoma (UPSC) treated with cisplatin, doxorubicin, and cyclophosphamide (PAC). Gynecol Oncol. 1992 Sep;46(3):317-21. Ball HG, Blessing JA, Lentz SS, Mutch DG. A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study. Gynecol Oncol. 1996 Aug;62(2):278-81. Lincoln S, Blessing JA, Lee RB, Rocereto TF. Activity of paclitaxel as second-line chemotherapy in endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2003 Mar;88(3):277-81. Fleming GF, Brunetto VL, Cella D, Look KY, Reid GC, Munkarah AR, Kline R, Burger RA, Goodman A, Burks RT. Phase III trial of doxorubicin plus cisplatin with or without paclitaxel plus filgrastim in advanced endometrial carcinoma: a Gynecologic Oncology Group Study. J Clin Oncol. 2004 Jun 1;22(11):2159-66. Ramondetta L, Burke TW, Levenback C, Bevers M, Bodurka-Bevers D, Gershenson DM. Treatment of uterine papillary serous carcinoma with paclitaxel. Gynecol Oncol. 2001 Jul;82(1):156-61. Creasman WT, Morrow CP, Bundy BN, Homesley HD, Graham JE, Heller PB. Surgical pathologic spread patterns of endometrial cancer. A Gynecologic Oncology Group Study. Cancer. 1987 Oct 15;60(8 Suppl):2035-41.
Starting date: June 2011
Last updated: August 20, 2015
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