Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
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ClinicalTrials.gov Identifier: NCT00400205 |
Recruitment Status :
Terminated
(Safety reasons)
First Posted : November 16, 2006
Results First Posted : January 4, 2011
Last Update Posted : November 6, 2017
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Sponsor:
Emory University
Collaborator:
Sanofi
Information provided by (Responsible Party):
Nabil F. Saba, Emory University
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Tracking Information | ||||
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First Submitted Date ICMJE | November 15, 2006 | |||
First Posted Date ICMJE | November 16, 2006 | |||
Results First Submitted Date ICMJE | December 6, 2010 | |||
Results First Posted Date ICMJE | January 4, 2011 | |||
Last Update Posted Date | November 6, 2017 | |||
Study Start Date ICMJE | August 2006 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors) [ Time Frame: every 3 months ] Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00400205 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Tumor Change by Baseline Acetylated Tubulin Expression Score [ Time Frame: Baseline, After 3 cycles of study treatment ] Percent change in TNM stage of tumors after three cycles of study treatment was assessed to see if baseline acetylated tubulin (AT) expression predicts treatment success. Decreasing tumor stage change (a negative number) indicates that the tumor is responding to treatment while an increase means that the severity of the tumor is not decreasing. Immunohistochemistry (IHC) analysis of AT expression was performed in formalin-fixed, paraffin-embedded, pre-treatment tissues. The staining was scored based upon intensity according to the following criteria: 0=no staining, 1+=weak tumor staining, 2+=moderate tumor staining, 3+=moderate to high tumor staining, and 4+=high tumor staining.
Data presented are adopted from Saba, NF, et. al. Acetylated Tubulin (AT) as a Prognostic Marker in Squamous Cell Carcinoma of the Head and Neck. Head and Neck Pathology (2014) 8:66-72.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil | |||
Official Title ICMJE | Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints | |||
Brief Summary | This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells. | |||
Detailed Description | This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells. Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | Experimental: Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
Interventions:
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Publications * | Saba NF, Magliocca KR, Kim S, Muller S, Chen Z, Owonikoko TK, Sarlis NJ, Eggers C, Phelan V, Grist WJ, Chen AY, Ramalingam SS, Chen ZG, Beitler JJ, Shin DM, Khuri FR, Marcus AI. Acetylated tubulin (AT) as a prognostic marker in squamous cell carcinoma of the head and neck. Head Neck Pathol. 2014 Mar;8(1):66-72. doi: 10.1007/s12105-013-0476-6. Epub 2013 Jul 24. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
14 | |||
Original Enrollment ICMJE |
20 | |||
Actual Study Completion Date ICMJE | September 2009 | |||
Actual Primary Completion Date | September 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00400205 | |||
Other Study ID Numbers ICMJE | 0414-2006 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Nabil F. Saba, Emory University | |||
Study Sponsor ICMJE | Emory University | |||
Collaborators ICMJE | Sanofi | |||
Investigators ICMJE |
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PRS Account | Emory University | |||
Verification Date | October 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |