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Sponsors and Collaborators: |
University of Pittsburgh Millennium Pharmaceuticals, Inc. |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00581360 |
This is a Phase II trial non-randomized study to evaluate the objective response rate and stable disease rate (primary endpoints), progression-free survival, overall survival and toxicities with the combination of doxorubicin and bortezomib in patients with incurable head and neck adenoid cystic carcinoma. Also, we plan to collect tumor tissue from previous diagnostic procedures and baseline blood specimens for future correlative studies.
Condition | Intervention | Phase |
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Adenoid Cystic Carcinoma |
Drug: doxorubicin and bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Trial of Doxorubicin and Bortezomib in Patients With Incurable Head and Neck Adenoid Cystic Carcinoma |
Estimated Enrollment: | 35 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2012 |
Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
All subjects will receive doxorubicin and bortezomib
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Drug: doxorubicin and bortezomib
Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days 1,8,15, every 28 days, will be administered alone. Treatment will continue unless disease progression or intolerable toxicity emerges.
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Patients will be treated with bortezomib 1.3 mg/m2, intravenously on days 1, 4, 8 and 11, and doxorubicin 20 mg/m2, intravenously on days 1 and 8, every 21 days. Zinecard will be added at the 8th cycle and all subsequent cycles with doxorubicin. After the completion of 14 cycles, if there is no progression, bortezomib once a week at a dose of 1.6 mg/m2 on days 1,8,15, every 28 days, will be administered alone. Treatment will continue unless disease progression or intolerable toxicity emerges (see section 5 for detailed treatment plan and dose modifications).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Athanassios E Argiris, MD | 412-648-6619 | argirisae@upmc.edu |
Contact: Rita Johnson, RN, BSN | 412-647-8571 | johnsonr1@upmc.edu |
United States, Ohio | |
UPMC Cancer Center - Teramana Cancer Center - Steubenville | Recruiting |
Steubenville, Ohio, United States, 43952 | |
United States, Pennsylvania | |
University of Pittsburgh Cancer Institute-Hillman Cancer Center | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Principal Investigator: Athanassios E Argiris, MD | |
UPMC Cancer Center - Arnold Palmer Pavilion - Greensburg | Recruiting |
Greensburg, Pennsylvania, United States, 15601 | |
UPMC Cancer Center - Beaver | Recruiting |
Beaver, Pennsylvania, United States, 15009 | |
UPMC Cancer Center - Clairton | Recruiting |
Clairton, Pennsylvania, United States, 15025 | |
UPMC Cancer Center - Indiana | Recruiting |
Indiana, Pennsylvania, United States, 15701 | |
UPMC Cancer Center - John P. Murtha Pavilion - Johnstown | Recruiting |
Johnstown, Pennsylvania, United States, 15901 | |
UPMC Cancer Center - McKeesport | Recruiting |
McKeesport, Pennsylvania, United States, 15132 | |
UPMC Cancer Center - Mercy | Recruiting |
Pittsburgh, Pennsylvania, United States, 15219 | |
UPMC Cancer Center - Oakbrook Commons - Greensburg | Recruiting |
Greensburg, Pennsylvania, United States, 15601 | |
UPMC Cancer Center -Wexford | Recruiting |
Wexford, Pennsylvania, United States, 15090 | |
UPMC Cancer Center - Sewickley Medical Oncology/Hematology Group | Recruiting |
Moon Township, Pennsylvania, United States, 15108 | |
UPMC Cancer Center - Uniontown | Recruiting |
Uniontown, Pennsylvania, United States, 15401 | |
UPMC Cancer Center - Washington | Recruiting |
Washington, Pennsylvania, United States, 15301 | |
UPMC Cancer Center -Delafield Rd. | Recruiting |
Pittsburgh, Pennsylvania, United States, 15215 | |
UPMC Cancer Center -Drake | Recruiting |
Pittsburgh, Pennsylvania, United States, 15241 | |
UPMC Cancer Center -Haymaker Rd. | Recruiting |
Monroeville, Pennsylvania, United States, 15146 | |
UPMC Cancer Center -Mosside Blvd. | Recruiting |
Monroeville, Pennsylvania, United States, 15146 | |
UPMC Cancer Center -Mt. Pleasant | Recruiting |
Mt. Pleasant, Pennsylvania, United States, 15666 | |
UPMC Cancer Center -New Castle | Recruiting |
New Castle, Pennsylvania, United States, 16105 | |
UPMC Cancer Center - Passavant | Recruiting |
Pittsburgh, Pennsylvania, United States, 15237 |
Principal Investigator: | Athanassios E Argiris, MD | Principal Investigator |
Responsible Party: | University of Pittsburgh ( Athanassios Argiris, MD/ Principal Investigator ) |
Study ID Numbers: | 06-124 |
Study First Received: | December 19, 2007 |
Last Updated: | October 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00581360 |
Health Authority: | United States: Institutional Review Board |
Adenoid cystic carcinoma bortezomib doxorubicin |
Carcinoma, Adenoid Cystic Bortezomib Adenocarcinoma Doxorubicin |
Adenoid cystic carcinoma Razoxane Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Antibiotics, Antineoplastic Pharmacologic Actions Protease Inhibitors |