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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

Tracking Information
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
 (submitted: March 1, 2011)
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)].
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2006)
  • Response rate
  • Percentage pathological complete response rate
  • After 3 cycles of induction chemotherapy at 12 weeks
Change History Complete list of historical versions of study NCT00400205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2017)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2006)
  • Study incidence of beta-I tubulin mutations (gene M40)
  • and beta-I tubulin loss of heterozygosity in squamous
  • cell carcinoma of the oral cavity and correlate with
  • clinical sensitivity resistance to Docetaxel induction
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Squamous Cell Carcinoma
  • Oral Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
    Other Name: Taxotere
  • Drug: Cisplatin
    Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
  • Drug: 5-fluorouracil
    5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
Study Arms  ICMJE Experimental: Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
Interventions:
  • Drug: Docetaxel
  • Drug: Cisplatin
  • Drug: 5-fluorouracil
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.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 6, 2010)
14
Original Enrollment  ICMJE
 (submitted: November 15, 2006)
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:

  • Histologically or cytologically proven squamous cell carcinoma of the oral cavity.
  • Primary tumor sites eligible: oral cavity. Although they are admittedly of squamous cell types, the following tumors will be excluded because their responsiveness to chemotherapy may differ: tumors of the nasal and paranasal cavities and of the nasopharynx. Oral cavity tumors with mandible invasion are excluded because the tumor biology and management of these tumors is more complex and will likely include upfront surgical resection.
  • Stage 3 or 4 disease without evidence of distant metastases verified by chest x-ray, abdominal ultrasound, or CT scan (liver function test abnormalities); bone scan in case of local symptoms.
  • At least one uni- or bi-dimensionally measurable lesion.
  • Age ≥ 18 years.
  • World Health Organization (WHO) performance status of 2 or less.
  • No active alcohol addiction.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

  • Pregnant or breast feeding
  • Previous malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal, or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
  • Any prior treatment with radiotherapy or chemotherapy is an exclusion criterion.
  • Patients who experience an involuntary weight loss of more than 25% of their body weight in the 2 months preceding study entry.
  • Concurrent treatment with any other anti-cancer therapy.
  • Participation in an investigational trial within 30 days of study entry.
  • Patients with a history of severe hypersensitivity reaction to Taxotere® or other drugs formulated with polysorbate 80.
  • No previous chemotherapy or radiotherapy for any reason and no previous surgery for SCCHN [squamous cell carcinoma of the head and neck] (other than biopsy) are allowed at the time of study entry.
  • Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Nabil Saba, MD Emory University Winship Cancer Institute
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