Clinical trial · Interventional
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
A Phase II Safety, Efficacy, and Feasibility Study of Neoadjuvant ZD1839 (IRESSA) in Resectable Esophageal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn for lack of funding and accrual
Summary
Brief summary (as posted)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gefitinib before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| enzyme inhibitor therapy | Procedure | — | UNRESOLVED |
| gefitinib | Drug | Gefitinib | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| protein tyrosine kinase inhibitor therapy | Procedure | — | UNRESOLVED |
| surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus * Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0) * Stage I-III disease * No known distant metastases * No cervical-esophageal tumors (upper border \< 18 cm from the incisor teeth) * No supraclavicular metastases PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Adequate bone marrow function Hepatic * Adequate hepatic function * No unstable or uncompensated hepatic disease Renal * Creatinine ≤ grade 2 by Common Toxicity Criteria * Adequate renal function * No unstable or uncompensated renal disease Cardiovascular * No unstable or uncompensated cardiac disease Pulmonary * No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes * No unstable or uncompensated respiratory disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No known hypersensitivity to gefitinib or any of the excipients * No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix * No evidence of severe or uncontrolled systemic disease * No other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Endocrine therapy * Concurrent stable-dose steroids allowed Surgery * Recovered from any prior oncologic or other major surgery Other * More than 30 days since prior nonapproved or investigational drug * No prior therapy for this or any other malignancy * No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)
References
Publications (0)
Data not yet available