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Tracking Information | |||||||||||||
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First Received Date † | February 10, 2004 | ||||||||||||
Last Updated Date | July 23, 2008 | ||||||||||||
Start Date † | June 2004 | ||||||||||||
Current Primary Outcome Measures † |
Objective tumor response [ Designated as safety issue: No ] | ||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||
Change History | Complete list of historical versions of study NCT00077428 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Bortezomib Followed by the Addition of Doxorubicin at Disease Progression in Treating Patients With Locally Advanced, Recurrent, or Metastatic Adenoid Cystic Carcinoma (Cancer) of the Head and Neck | ||||||||||||
Official Title † | Phase II Trial of PS-341 (NSC 681239) Followed by the Addition of Doxorubicin at Progression in Advanced Adenoid Cystic Carcinoma of the Head and Neck | ||||||||||||
Brief Summary | RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining bortezomib with doxorubicin may kill more tumor cells. PURPOSE: This phase II trial is studying how well bortezomib followed by doxorubicin at the time of disease progression works in treating patients with locally advanced, recurrent, or metastatic adenoid cystic carcinoma (cancer) of the head and neck. |
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Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a multicenter study. Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression continue to receive bortezomib as above and doxorubicin IV over 2-5 minutes on days 1 and 8. Treatment repeats every 21 days for up to 14 courses in the absence of further disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 8 years. PROJECTED ACCRUAL: A total of 23-37 patients will be accrued for this study within 2.3 years. |
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Study Phase | Phase II | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Open Label | ||||||||||||
Condition † | Head and Neck Cancer | ||||||||||||
Intervention † |
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Study Arms / Comparison Groups | |||||||||||||
Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Completed | ||||||||||||
Enrollment † | |||||||||||||
Completion Date | |||||||||||||
Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||||||||||
Ages | 18 Years and older | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00077428 | ||||||||||||
Responsible Party | |||||||||||||
Secondary IDs †† | ECOG-E1303, SWOG-ECOG-E1303 | ||||||||||||
Study Sponsor † | Eastern Cooperative Oncology Group | ||||||||||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | August 2007 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |