Status:
TERMINATED
Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
Lead Sponsor:
Emory University
Collaborating Sponsors:
Sanofi
Conditions:
Squamous Cell Carcinoma
Oral Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 determi...
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 eff...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00400205
Start Date
August 1 2006
End Date
September 1 2009
Last Update
November 6 2017
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322