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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

Page last updated: August 23, 2015

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