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A Phase I Study Of ZD 1839 In Combination With Radiation And Chemotherapy In Locally Advanced Squamous Cell Carcinoma Of The Head And Neck
This phase I trial is studying the side effects and best dose of gefitinib when given together with radiation therapy with or without cisplatin in treating patients with stage III or stage IV head and neck cancer. Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining gefitinib and radiation therapy with cisplatin may kill more tumor cells
Details
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1 |
| Status | TERMINATED |
| Enrolment | 30 |
| Start date | 2002-02 |
Conditions
- Stage III Squamous Cell Carcinoma of the Hypopharynx
- Stage III Squamous Cell Carcinoma of the Larynx
- Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage III Squamous Cell Carcinoma of the Oropharynx
- Stage IV Squamous Cell Carcinoma of the Hypopharynx
- Stage IV Squamous Cell Carcinoma of the Larynx
- Stage IV Squamous Cell Carcinoma of the Lip and Oral Cavity
- Stage IV Squamous Cell Carcinoma of the Oropharynx
Interventions
- gefitinib
- radiation therapy
- cisplatin
- laboratory biomarker analysis
Primary outcomes
- Incidence of grade 4 or greater mucositis as scored by the National Cancer Institute (NCI) Common Toxicity Criteria v2.0 — Up to 2 years
Descriptive statistics (mean, median, range, standard deviation \[s.d.\], percentage, as appropriate) will be obtained. - Incidence of grade 4 or greater skin toxicity as scored by the NCI Common Toxicity Criteria v2.0 — Up to 2 years
Descriptive statistics (mean, median, range, s.d., percentage, as appropriate) will be obtained. - Incidence of any other grade 4 or greater toxicity as scored by the NCI Common Toxicity Criteria v2.0 — Up to 2 years
Descriptive statistics (mean, median, range, s.d., percentage, as appropriate) will be obtained.
Countries
United States