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Trial record 45 of 6995 for:    Oral Cancer | ( Map: United States )

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
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Nabil F. Saba, Emory University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Squamous Cell Carcinoma
Oral Cancer
Interventions Drug: Docetaxel
Drug: Cisplatin
Drug: 5-fluorouracil
Enrollment 14
Recruitment Details Accrual period is from Aug 2006 through Jul 2009. Accrual of 14 patients.
Pre-assignment Details A total of 14 patients with squamous carcinoma were enrolled. All patients had stage 4a or 4b disease and had a performance status of 0-2 then all had measurable lesions on imaging. The study closed prematurely due to slow accrual and increased observed complications.
Arm/Group Title Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Hide Arm/Group Description Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
Period Title: Overall Study
Started 14
Completed 9
Not Completed 5
Arm/Group Title Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Hide Arm/Group Description Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
6
  42.9%
Male
8
  57.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
Tumor Stage IV   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 14 participants
14
[1]
Measure Description: Cancer stage was assessed with the tumor, node and metastasis (TNM) staging system. The TNM Classification of Malignant Tumors is a commonly used system of assessing cancer severity. Stage IV refers to cancer that has spread to distant body parts and is the most severe stage.
1.Primary Outcome
Title Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
Hide Description Complete remission (complete disappearance of disease), partial remission [more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)].
Time Frame every 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Hide Arm/Group Description:
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatin, and 5-fluorouracil
Overall Number of Participants Analyzed 9
Measure Type: Number
Unit of Measure: participants
8
2.Secondary Outcome
Title Tumor Change by Baseline Acetylated Tubulin Expression Score
Hide Description

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.

Time Frame Baseline, After 3 cycles of study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed the study are included in this analysis.
Arm/Group Title Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Hide Arm/Group Description:
Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
Overall Number of Participants Analyzed 9
Mean (Standard Deviation)
Unit of Measure: percentage of tumor stage change
AT score less than or equal to 2 Number Analyzed 4 participants
-0.8  (0.23)
AT score greater than 2 Number Analyzed 5 participants
-0.36  (0.44)
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Hide Arm/Group Description Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with docetaxel, cisplatin, and 5-fluorouracil followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
All-Cause Mortality
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Affected / at Risk (%)
Total   3/14 (21.43%)    
Show Serious Adverse Events Hide Serious Adverse Events
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Affected / at Risk (%) # Events
Total   6/14 (42.86%)    
General disorders   
Death *  1/14 (7.14%)  1
Infections and infestations   
Death   1/14 (7.14%)  1
Fever neutropenia *  1/14 (7.14%)  1
PEG tube infection *  1/14 (7.14%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death *  1/14 (7.14%)  1
Nervous system disorders   
Stroke *  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxemia *  1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Affected / at Risk (%) # Events
Total   14/14 (100.00%)    
Blood and lymphatic system disorders   
Anemia *  3/14 (21.43%)  3
Hypokalemia *  6/14 (42.86%)  7
Eye disorders   
Vision disturbance *  2/14 (14.29%)  2
Gastrointestinal disorders   
Abdominal pain *  5/14 (35.71%)  6
Constipation *  6/14 (42.86%)  7
Diarrhea *  6/14 (42.86%)  9
Heartburn   3/14 (21.43%)  3
Mucositis *  10/14 (71.43%)  21
Odynophagia *  5/14 (35.71%)  15
Mouth sores *  5/14 (35.71%)  5
General disorders   
Dizziness *  6/14 (42.86%)  12
Dry mouth * 1  4/14 (28.57%)  4
Fatigue *  12/14 (85.71%)  23
Fever *  6/14 (42.86%)  11
Insomnia *  11/14 (78.57%)  12
Loss of appetite *  9/14 (64.29%)  10
Mouth pain *  12/14 (85.71%)  37
Nausea *  9/14 (64.29%)  13
Vomiting *  5/14 (35.71%)  5
Weakness *  7/14 (50.00%)  8
Weight loss *  9/14 (64.29%)  16
Infections and infestations   
Oral thrush *  7/14 (50.00%)  7
Metabolism and nutrition disorders   
Dehydration   7/14 (50.00%)  7
Edema *  6/14 (42.86%)  8
Musculoskeletal and connective tissue disorders   
Facial pain *  4/14 (28.57%)  4
Neck pain *  6/14 (42.86%)  9
Nervous system disorders   
Neuropathy *  4/14 (28.57%)  4
Restlessness *  3/14 (21.43%)  3
Psychiatric disorders   
Anxiety *  7/14 (50.00%)  8
Depression *  5/14 (35.71%)  5
Respiratory, thoracic and mediastinal disorders   
Cough *  6/14 (42.86%)  8
Difficulty speaking *  1/14 (7.14%)  1
Dysphagia *  8/14 (57.14%)  10
Shortness of breath *  3/14 (21.43%)  4
Skin and subcutaneous tissue disorders   
Cellulitis *  7/14 (50.00%)  9
1
Term from vocabulary, xerostomia
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Nabil Saba, MD
Organization: Emory University Winship Cancer Institute
Phone: 1-888-946-7447
Responsible Party: Nabil F. Saba, Emory University
ClinicalTrials.gov Identifier: NCT00400205     History of Changes
Other Study ID Numbers: 0414-2006
First Submitted: November 15, 2006
First Posted: November 16, 2006
Results First Submitted: December 6, 2010
Results First Posted: January 4, 2011
Last Update Posted: November 6, 2017