Clinical trial · Interventional
Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer
A Phase II Trial of ZD1839 (IRESSA®) for Patients With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction
NCT00268346CI-TRIAL-00020434completedPhase 2Results postedClinicalTrials.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 recurrent or metastatic esophageal or gastroesophageal junction 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 |
|---|---|---|---|
| ZD1839 | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ZD1839
- interventionNames
- Drug: ZD1839
Primary outcomes (1)
- measure
- The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.
- timeFrame
- at 8 weeks after initiation of treatment
- description
- The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologically confirmed squamous cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus or gastroesophageal junction * Patients must have disease that is either metastatic (i.e., M1b by the definitions of the American Joint Committee on Cancer 1997 staging system) or recurrent after definitive therapy, and must be considered incurable by conventional treatments * Patients with small cell, or mixed small cell/non-small-cell histology are ineligible * Patients with lymphoma or sarcoma are also ineligible * Disease must be measurable in at least one dimension by physical exam, x-ray, CT scan or MRI, ultrasound, or endoscopy * Measurable disease can be a previously irradiated lesion if disease growth has been documented in the lesion since completion of radiation therapy * An elevation in carcinoembryonic antigen (CEA) is not sufficient to use by itself in response assessment PATIENT CHARACTERISTICS: * ECOG Performance Status 0-1 * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Creatinine ≤ 2.0 mg/dL * Alkaline phosphatase and AST \< twice normal * Bilirubin \< twice normal * Calcium normal * No known severe hypersensitivity to study drug or any of its excipients * No clinical evidence of any other uncontrolled malignancy except adequately treated basal or squamous cell skin cancer or in situ cervical cancer * Pregnant or nursing women are ineligible * Fertile patients must use effective contraception * No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease) * No evidence of clinically active interstitial lung disease * Patients with chronic stable radiographic changes who are asymptomatic need not be excluded PRIOR CONCURRENT THERAPY: * Patients may not have received more than one previous systemic treatment regimen * Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease * Previously untreated patients are also eligible * No previous treatment with study drug or any other epidermal growth factor receptor (EGFR) antagonists * More than 30 days since prior treatment with a non-approved or investigational drug * At least 4 weeks must have elapsed since any surgery, radiation therapy, or chemotherapy administration * Recovered from previous oncologic or other major surgery * No concurrent barbiturates (e.g., phenytoin), carbamazepine, rifampicin, phenobarbital or Hypericum perforatum (St. John's wort) * No concurrent surgery, radiation therapy, hormonal therapy, or other chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.