Clinical trial · Interventional
Gefitinib, Paclitaxel, and Radiation Therapy in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Head and Neck
A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
NCT00083057CI-TRIAL-00006501completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving gefitinib and paclitaxel together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of gefitinib and paclitaxel when given together with radiation therapy in treating patients with advanced or recurrent squamous cell carcinoma (cancer) of the head and neck.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) as assessed by CTC v. 3.0
Secondary outcomes (2)
- measure
- Molecular targets analysis of epidermal growth factor receptor (EGFR) downstream signaling pathway as assessed by tissue biopsies and serum cytokines at baseline, days 8 and 29, and 12 weeks after completion of study treatment
- measure
- Efficacy as assessed by imagining, histologically, and clinically at 3 months after completion of study treatment and annually for 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed squamous cell (epidermoid) carcinoma of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, or maxillary sinus
* Stage III or IV disease
* Distant metastases allowed provided both of the following are true:
* Metastases are confined to the head and neck region
* Metastases are encompassable in a radiotherapy field with curative intent
* Locally recurrent disease after primary surgery allowed
* Meets 1 of the following criteria:
* Unresectable disease
* Patient prefers chemoradiotherapy over surgery
* Measurable disease
* No brain metastases and/or carcinomatous meningitis
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Hemoglobin \> 10 g/dL
* Platelet count \> 100,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
Hepatic
* Bilirubin \< 2.0 times upper limit of normal (ULN)
* AST/ALT ≤ 2.5 times ULN
Renal
* Creatinine \< 1.5 times ULN OR
* Creatinine clearance ≥ 60 mL/min
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Pulmonary
* No clinically active interstitial lung disease
* Chronic, stable, asymptomatic radiographic changes allowed
Other
* No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs or Cremophor\^® EL
* No AIDS or primary immunodeficiencies
* No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* Probability of recurrence of the prior malignancy \< 5%
* No other concurrent uncontrolled illness
* No ongoing or active serious infection
* No psychiatric illness or situation that would preclude study compliance or giving informed consent
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for cancer
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior therapeutic radiotherapy to the head and neck region
* No prior radiotherapy for cancer
Surgery
* See Disease Characteristics
* At least 4 weeks since prior major surgery and recovered
Other
* No prior gefitinib or other epidermal growth factor receptor inhibitors
* More than 4 weeks since prior non-approved or investigational agents
* No concurrent administration of any of the following:
* Phenytoin
* Carbamazepine
* Barbiturates
* Rifampin
* Hypericum perforatum (St. John's wort)
* Oxcarbazepine
* Rifapentine
* Amifostine
* Modafinil
* Other CYP3A4 enzyme inducers
* Other anticancer agents or investigational drugs
* Combination antiretroviral therapy for HIV-positive patientsReferences
Publications (3)
- RESULTVan Waes C, Allen CT, Citrin D, Gius D, Colevas AD, Harold NA, Rudy S, Nottingham L, Muir C, Chen Z, Singh AK, Dancey J, Morris JC. Molecular and clinical responses in a pilot study of gefitinib with paclitaxel and radiation in locally advanced head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):447-54. doi: 10.1016/j.ijrobp.2009.05.037. Epub 2009 Oct 30. PMID 19879702
- RESULTSharp H, Morris JC, Van Waes C, Gius D, Cooley-Zgela T, Singh AK. High incidence of oral dysesthesias on a trial of gefitinib, Paclitaxel, and concurrent external beam radiation for locally advanced head and neck cancers. Am J Clin Oncol. 2008 Dec;31(6):557-60. doi: 10.1097/COC.0b013e318172d5de. PMID 19060587
- RESULTSharp HJ, Morris JC, Van Waes C, et al.: A high incidence of oral dysesthesias unrelated to mucositis in a pilot trial of gefitinib, paclitaxel and concurrent external beam radiation in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-1101, S188-9, 2006.