Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
This study is currently recruiting participants.
Verified May 2013 by Yale University
Sponsor:
Yale University
Collaborator:
Genentech
Information provided by (Responsible Party):
Alessandro Santin, Yale University
ClinicalTrials.gov Identifier:
NCT01367002
First received: May 26, 2011
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: Carboplatin/Paclitaxel Drug: Trastuzumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- Progression free survival differences between Arm A versus Arm B. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]Progression free survival differences between Arm A versus Arm B.
Secondary Outcome Measures:
- To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0 [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]To assess the safety profile of trastuzumab in USPC patients by CTCAE v4.0.
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Carboplatin/Paclitaxel
Chemotherapy
|
Drug: Carboplatin/Paclitaxel
Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
Other Names:
|
|
Experimental: Trastuzumab
Monoclonal antibody
|
Drug: Trastuzumab
Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
Other Name: Herceptin
|
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| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01367002
Contacts
| Contact: Alessandro D Santin, M.D. | 203-737-4450 | alessandro.santin@yale.edu |
| Contact: Martha Luther, R.N. | 203-737-2781 | martha.luther@yale.edu |
Locations
| United States, Arizona | |
| St. Joseph's Hospital and Medical Center | Recruiting |
| Pheonix, Arizona, United States, 85013 | |
| Contact: Dana Chase, M.D. 602-406-7730 dana.chase@dignityhealth.org | |
| Contact: Kelli Williamson, RN, MPH 602-406-689 kelli.williamson@dignityhealth.org | |
| Principal Investigator: Dana Chase, M.D. | |
| United States, California | |
| John Muir Clinical Research Center | Recruiting |
| Concord, California, United States, 94520 | |
| Contact: Babak Edraki, M.D. 925-674-2580 babak.edraki@johnmuirhealth.com | |
| Contact: Peggy Newsom 925-674-2198 peggy.newsom@johhmuirhealth.com | |
| Principal Investigator: Babak Edraki, M.D. | |
| University of California at Los Angeles | Not yet recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Gottfried Konecny, M.D. 310-586-2652 gkonecny@mednet.ucla.edu | |
| Contact: Christy Palodichuk | |
| Principal Investigator: Gottfried Konecny, M.D. | |
| United States, Connecticut | |
| University of Connecticut Health Center | Recruiting |
| Farmington, Connecticut, United States, 06030 | |
| Contact: Molly A. Brewer, DVM, MD, MS 860-679-1731 mbrewer@uchc.edu | |
| Contact: Paige C. Dunion, MS, CCRP 860-679-6571 | |
| Principal Investigator: Molly A. Brewer, DVM, MD, MS | |
| Smilow Cancer Hospital at Yale New Haven | Recruiting |
| New Haven, Connecticut, United States, 06510 | |
| Contact: Alessandro D Santin, M.D. 203-737-4450 alessandro.santin@yale.edu | |
| Contact: Martha Luther, R.N. 203-737-2781 martha.luther@yale.edu | |
| Principal Investigator: Alessandro Santin, M.D. | |
| United States, Maryland | |
| Greater Baltimore Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21204 | |
| Contact: Amanda Nickles-Fader, M.D. 443-803-0235 amandafader@gmail.com | |
| Contact: Tahisa Hamwright, B.S. 443-849-3123 thamwright@gbmc.org | |
| Principal Investigator: Amanda Nickles-Fader, M.D. | |
| Holy Cross Hospital | Not yet recruiting |
| Silver Springs, Maryland, United States, 20910 | |
| Contact: Cheryl Aylesworth, M.D. 301-754-7552 cheryl.aylesworth@gmail.com | |
| Contact: Lyudmila Kalnitskaya 301-754-7552 kalnitsl@holycrosshealth.org | |
| Principal Investigator: Cheryl Aylesworth, M.D. | |
| United States, New Jersey | |
| Jersey Shore University Medical Center | Recruiting |
| Neptune, New Jersey, United States, 07753 | |
| Contact: Karim El-Sahwi, M.D. 732-776-3790 kelsahwi@meridianhealth.com | |
| Contact: Diane Russomanno 732-776-3790 drussomanno@meridianhealth.com | |
| Principal Investigator: Karim El-Sahwi, M.D. | |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10461 | |
| Contact: June Hou, M.D. 718-405-8082 yhou@montefiore.org | |
| Contact: Randy Teeter 718-405-8395 rteeter@montefiore.org | |
| Principal Investigator: June Hou, M.D. | |
| United States, North Carolina | |
| University of North Carolina | Recruiting |
| Chapel Hill, North Carolina, United States, 27514 | |
| Contact: Paola Gehrig, M.D. 919-966-2131 paola_gehrig@med.unc.edu | |
| Contact: Ellen M. Cohen, Ph.D. 919-843-2448 ellen_cohen@med.unc.edu | |
| Principal Investigator: Paola Gehrig, M.D. | |
| Duke University School of Medicine | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Laura J. Havrilesky, M.D. 919-684-3765 laura.havrilesky@duke.edu | |
| Contact: Sonja G. Hunter, AAS 919-684-9074 sonja.hunter@duke.edu | |
| Principal Investigator: Laura J Havrilesky, M.D. | |
| United States, Ohio | |
| The Ohio State University | Recruiting |
| Hilliard, Ohio, United States, 43026 | |
| Contact: David O'Malley, M.D. 614-293-7642 david.o'malley@osumc.edu | |
| Contact: Michele Vaughan, B.S. 614-366-9088 michele.vaughan@osumc.edu | |
| Principal Investigator: David O'Malley, M.D. | |
| United States, Virginia | |
| University of Virginia | Recruiting |
| Charlottesville, Virginia, United States, 22908 | |
| Contact: Heather Lothamer, M.S.N., C.C.R.P. 434-924-9924 hll5y@hscmail.mcc.virginia.edu | |
| Sub-Investigator: Leigh Cantrell, M.D. | |
Sponsors and Collaborators
Yale University
Genentech
Investigators
| Principal Investigator: | Alessandro D Santin, M.D. | Yale University |
More Information
Publications:
| Responsible Party: | Alessandro Santin, M.D., Yale University |
| ClinicalTrials.gov Identifier: | NCT01367002 History of Changes |
| Other Study ID Numbers: | 1012007786 |
| Study First Received: | May 26, 2011 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
Uterine serous papillary carcinoma Type II endometrial cancer HER2/neu Paclitaxel, Carboplatin, Trastuzumab |
Additional relevant MeSH terms:
|
Endometrial Neoplasms Carcinoma, Papillary Adenoma Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms, Squamous Cell Trastuzumab Carboplatin Paclitaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 22, 2013