Gefitinib and Radiation Therapy With or Without Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00033449
First received: April 9, 2002
Last updated: January 24, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: gefitinib Radiation: radiation therapy Drug: cisplatin Other: laboratory biomarker analysis |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of ZD 1839 In Combination With Radiation And Chemotherapy In Locally Advanced Squamous Cell Carcinoma Of The Head And Neck |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Incidence of grade 4 or greater mucositis as scored by the National Cancer Institute (NCI) Common Toxicity Criteria v2.0 [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]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 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Descriptive statistics (mean, median, range, s.d., percentage, as appropriate) will be obtained.
Secondary Outcome Measures:
- Primary tumor response rate as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Estimated with its 95% confidence interval.
- Response rates as assessed by the RECIST [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Estimated with its 95% confidence interval.
- Relapse-free survival rates [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
- Overall survival rates [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]Estimated using Kaplan-Meier curves.
- Biological effects of gefitinib within the primary tumor and skin [ Time Frame: Baseline ] [ Designated as safety issue: No ]Examined using linear or nonlinear mixed models. Reductions of labeling scores that are of prognostic importance will be determined by relating labeling scores to survival scores by statistical methods such as the Cox proportional hazards regression model.
| Enrollment: | 30 |
| Study Start Date: | February 2002 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (gefitinib, radiation therapy, cisplatin)
See detailed description.
|
Drug: gefitinib
Given orally
Other Names:
Radiation: radiation therapy
Undergo radiation therapy
Other Names:
Drug: cisplatin
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Histologically confirmed locally advanced squamous cell carcinoma of the head and neck involving the oral cavity, oropharynx, hypopharynx, or supraglotticor glottic larynx
Unresectable disease
- Medically inoperable resectable disease allowed
Stage III or IV
- No distant metastases
- Only patients with intermediate stage disease (T1-2, N1-N2a or T3, N0-1) are eligible for radiotherapy alone with gefitinib
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 6 months
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Medically suitable to withstand a course of definitive radiotherapy
- No ongoing or active infection
- No other malignancy within the past 3 years except basal cell skin cancer or carcinoma in situ of the cervix
- No prior allergic reactions to compounds of similar chemical or biological composition to gefitinib or other study agents
- No uncontrolled concurrent medical or psychiatric illness or social situation that would preclude study participation
- No prior monoclonal antibodies with potential epidermal growth factor receptor (EGFR) binding therapy
- No prior chemotherapy
- No prior radiotherapy
- No prior surgery except biopsy
- No prior anti-EGFR therapy including prior tyrosine kinase inhibitors
- No concurrent combination anti-retroviral therapy for HIV-positive patients
- No other concurrent investigational agents
- No other concurrent commercial or investigational agents or therapies intended to treat the malignancy
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00033449 History of Changes |
| Other Study ID Numbers: | NCI-2012-02462, UCHSC-01460, CDR0000069284 |
| Study First Received: | April 9, 2002 |
| Last Updated: | January 24, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Laryngeal Diseases Hypopharyngeal Neoplasms Laryngeal Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site Respiratory Tract Diseases Otorhinolaryngologic Diseases Pharyngeal Neoplasms |
Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Neoplasms Gefitinib Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013