Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
- Conditions
- Squamous Cell CarcinomaOral Cancer
- Interventions
- Registration Number
- NCT00400205
- Lead Sponsor
- Emory University
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 14
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Recipients of Docetaxel, Cisplatin, 5-Fluorouracil Cisplatin Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil. Recipients of Docetaxel, Cisplatin, 5-Fluorouracil Docetaxel Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil. Recipients of Docetaxel, Cisplatin, 5-Fluorouracil 5-fluorouracil Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
- Primary Outcome Measures
Name Time Method Number of Patients Who Had Response by RECIST Criteria (Response Evaluation Criteria in Solid Tumors) every 3 months Complete remission (complete disappearance of disease), partial remission \[more than 30% decrease in tumor measurement by RECIST (Response evaluation criteria in solid tumors)\].
- Secondary Outcome Measures
Name Time Method Tumor Change by Baseline Acetylated Tubulin Expression Score 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.
Trial Locations
- Locations (1)
Emory University Winship Cancer Institute
🇺🇸Atlanta, Georgia, United States