Clinical trial · Interventional
Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Phase II Study Of OSI-774 In Advanced Esophageal Cancer
NCT00045526CI-TRIAL-00010570completedPhase 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)
This phase II trial is studying erlotinib hydrochloride to see how well it works in treating patients with advanced esophageal cancer or stomach cancer. Erlotinib hydrochloride may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Esophagus | Esophageal Adenocarcinoma | ALIAS | 0.90 |
| Adenocarcinoma of the Gastroesophageal Junction | Gastroesophageal Junction Adenocarcinoma | ALIAS | 0.90 |
| Recurrent Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Squamous Cell Carcinoma of the Esophagus | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
| Stage III Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
| Stage IV Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (erlotinib hydrochloride)
- description
- Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: erlotinib hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Major response rate (complete and partial response)
- timeFrame
- Up to 5 years
Secondary outcomes (4)
- measure
- Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
- timeFrame
- Up to 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma, squamous cell or small cell carcinoma, or carcinoma not otherwise specified of the esophagus or gastroesophageal junction * Metastatic or surgically unresectable disease * Measurable disease outside of primary tumor * At least 20 mm by conventional techniques OR at least 10 mm by spiral computed tomography (CT) scan * No bone metastases, abnormal radionuclide bone scans, or pleural effusions as only site of measurable disease * No known brain metastases or carcinomatous meningitis * Must consent to having tumor tissue tested for epidermal growth factor receptor status * Performance status-Karnofsky 70-100% * Life expectancy of greater than 3 months * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin no greater than 2 times upper limit of normal (ULN) * Aspartate aminotransferase (AST) no greater than 2 times ULN * Creatinine no greater than 1.5 mg/dL * Calcium no greater than 12 mg/dL * No symptomatic hypercalcemia * No symptomatic congestive heart failure * No unstable angina pectoris * No ventricular arrhythmia * No other malignancy within the past 3 years except adequately treated carcinoma in situ of the cervix, superficial transitional cell carcinoma of the bladder, or basal cell or squamous cell skin cancer * No other uncontrolled concurrent illness * No ongoing or active infection * No psychiatric illness or social situation that would preclude study participation * No other concurrent disease that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior cetuximab * No more than 1 prior chemotherapy regimen for advanced or metastatic disease * One prior chemotherapy in the adjuvant setting (in combination with prior surgery or radiotherapy) allowed provided it was administered prior to treatment for advanced or metastatic disease * At least 3 weeks since prior chemotherapy * No concurrent investigational or commercial chemotherapy * At least 3 weeks since prior radiotherapy * No prior erlotinib-related compounds or compounds of similar biologic or chemical components * No prior EGFR-targeting compounds (e.g., gefitinib) * No other concurrent investigational agents * No concurrent combination antiretroviral therapy for human immunodeficiency virus (HIV)-positive patients
References
Publications (0)
Data not yet available
No reference posted for this study.