Clinical trial · Interventional
Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
NCT00100945CI-TRIAL-00025131completedPhase 2ClinicalTrials.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 some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.
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 |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gefitinib | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- gefitinib
- description
- Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity. Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment. Patients are followed every 3 months for up to 5 years.
- interventionNames
- Drug: gefitinib
Primary outcomes (1)
- measure
- 1-year overall survival rate
- timeFrame
- Up to 12 months
Secondary outcomes (5)
- measure
- Survival time
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
* Locally advanced disease
* T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement
* Celiac node involvement allowed
* No supraclavicular lymph node involvement
* Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months
* Patients who received adjuvant chemotherapy or chemoradiotherapy after surgery are eligible provided last treatment was administered within the past 3 months
* No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy
* No positive margins at the time of prior surgery
* No measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
Hepatic
* Bilirubin ≤ 2.0 mg/dL
Renal
* Creatinine ≤ 2 times upper limit of normal
Cardiovascular
* No New York Heart Association class III or IV heart disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Able to swallow study drug
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
Surgery
* See Disease Characteristics
Other
* No prior gefitinib
* No concurrent CYP3A4 inducing agents, including any of the following:
* Carbamazepine
* Oxcarbazepine
* Modafinil
* Ethosuximide
* Griseofulvin
* Nafcillin
* Phenobarbital
* Phenylbutazone
* Phenytoin
* Primidone
* Rifampin
* Hypericum perforatum (St. John's wort)
* Sulfinpyrazone
* No concurrent antacids 4 hours before or after study drug administrationReferences
Publications (1)
- DERIVEDSmith RS, Foster NR, Jatoi A, Thome SD, Miller RC. Incidence of Brain Metastasis as First Event in Patients with Esophageal Carcinoma: a Report from Three Prospective Alliance Clinical Trials. J Gastrointest Cancer. 2023 Sep;54(3):846-854. doi: 10.1007/s12029-022-00871-7. Epub 2022 Oct 17. PMID 36251211