Study Stopped
Safety reasons
Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
Phase II Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil Chemotherapy in Squamous Cell Carcinoma of the Oral Cavity With Molecular Endpoints
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 15, 2006
CompletedFirst Posted
Study publicly available on registry
November 16, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
January 4, 2011
CompletedNovember 6, 2017
October 1, 2017
3.1 years
November 15, 2006
December 6, 2010
October 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].
every 3 months
Secondary Outcomes (1)
Tumor Change by Baseline Acetylated Tubulin Expression Score
Baseline, After 3 cycles of study treatment
Study Arms (1)
Recipients of Docetaxel, Cisplatin, 5-Fluorouracil
EXPERIMENTALParticipants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
Interventions
Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks.
Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks.
5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Sanoficollaborator
Study Sites (1)
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Related Publications (1)
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.
PMID: 23881549RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nabil Saba, MD
- Organization
- Emory University Winship Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Nabil Saba, MD
Emory University Winship Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 15, 2006
First Posted
November 16, 2006
Study Start
August 1, 2006
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 6, 2017
Results First Posted
January 4, 2011
Record last verified: 2017-10