Clinical trial · Interventional
Oxaliplatin, Gefitinib, and Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer
ZD1839 (IRESSA®) With Oxaliplatin and Radiotherapy for Esophageal Carcinoma. A Phase I/II Study With Biologic Correlates
- 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: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining oxaliplatin and gefitinib with radiation therapy may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of oxaliplatin when given together with gefitinib and radiation therapy and to see how well they work in treating patients with locally advanced or metastatic 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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| gefitinib | Drug | Gefitinib | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Maximum tolerated dose (phase I)
- measure
- Response (phase II)
Secondary outcomes (4)
- measure
- Survival
- measure
- Quality of life
- measure
- Safety and toxicity
- measure
- Immunohistochemistry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal (GE) junction
* Locally advanced or metastatic disease by clinical staging, including esophagogastroduodenoscopy and esophageal ultrasound
* Stage T2, N0 disease and beyond
* Bulk of tumor must be in the esophagus of patients with GE junction tumor
* Bronchoscopy is required if primary esophageal tumor is \< 26 cm from the incisors
* No brain metastases
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* ECOG 0-1
Life expectancy
* At least 4 months
Hematopoietic
* WBC ≥ 3,000/mm\^3
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count \> 100,000/mm\^3
Hepatic
* Bilirubin normal
* ALT and AST ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
Renal
* Not specified
Cardiovascular
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
Pulmonary
* No clinically active interstitial lung disease
* Patients with chronic stable asymptomatic radiographic changes are eligible
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
* No peripheral neuropathy ≥ grade II
* No severe hypersensitivity to gefitinib or any of its excipients
* No history of allergy to platinum-based compounds or antiemetics administered with protocol-directed chemotherapy
* No active or ongoing infection
* No other uncontrolled illness
* No other significant clinical disorder or laboratory finding that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent colony-stimulating factors during course 1 of study therapy
Chemotherapy
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* Concurrent steroid therapy allowed
Radiotherapy
* More than 4 weeks since prior radiotherapy
Surgery
* Not specified
Other
* More than 30 days since prior non-approved or investigational drugs
* No concurrent administration of any of the following:
* Phenytoin
* Carbamazepine
* Rifampin
* Barbiturates
* Highly-active antiretroviral therapy (HAART)
* Hypericum perforatum (St. John's wort)
* No other concurrent investigational agents or therapyReferences
Publications (1)
- RESULTJavle M, Pande A, Iyer R, Yang G, LeVea C, Wilding G, Black J, Nava H, Nwogu C. Pilot study of gefitinib, oxaliplatin, and radiotherapy for esophageal adenocarcinoma: tissue effect predicts clinical response. Am J Clin Oncol. 2008 Aug;31(4):329-34. doi: 10.1097/COC.0b013e318161dc04. PMID 18845990