Study of Induction Docetaxel, Cisplatin and 5-Fluorouracil
Condition: Squamous Cell Carcinoma; Oral Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Mouth Neoplasms
Intervention: Docetaxel; Cisplatin; 5-fluorouracil
Intervention description: 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.
Intervention MeSH terms: Docetaxel; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous Cell Carcinoma of the Oral Cavity

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.
    

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.