Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil

• ClinicalTrials.gov Identifier: NCT00400205
• Recruitment Status: Terminated
• First Posted: November 16, 2006
• Results First Posted: January 4, 2011
• Last Update Posted: November 6, 2017
• Sponsor: Emory University
• Collaborator: Sanofi
• Information provided by (Responsible Party): Nabil F. Saba, Emory University

Tracking Information

• First Submitted Date: November 15, 2006
• First Posted Date: November 16, 2006
• Results First Submitted Date: December 6, 2010
• Results First Posted Date: January 4, 2011
• Last Update Posted Date: November 6, 2017
• Study Start Date: August 2006
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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 (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 (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: Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Squamous Cell Carcinoma
• Oral Cancer

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: December 6, 2010): 14
• Original Enrollment (submitted: November 15, 2006): 20
• Actual Study Completion Date: September 2009
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00400205
• Other Study ID Numbers: 0414-2006
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Nabil F. Saba, Emory University
• Study Sponsor: Emory University
• Collaborators: Sanofi

Investigators

• Principal Investigator: Nabil Saba, MD; Emory University Winship Cancer Institute

• PRS Account: Emory University
• Verification Date: October 2017