Clinical trial NCT00400205: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Squamous Cell Carcinoma
Oral Cancer
Keywords: Squamous Cell Carcinoma of the Oral Cavity
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2006-11-16
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors)
timeFrame: every 3 months
Secondary outcomes:
measure: Tumor Change by Baseline Acetylated Tubulin Expression Score
timeFrame: Baseline, After 3 cycles of study treatment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Nabil Saba, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.