Clinical trial · Interventional
Erlotinib in Treating Patients With Locally Advanced or Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
A Phase II Study Of OSI-774 (NSC 718781) In Unresectable Or Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
NCT00032123CI-TRIAL-00010996completedPhase 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: Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor. PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have locally advanced or metastatic stomach cancer or cancer of the gastroesophageal junction.
Conditions
Conditions (2)
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 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed adenocarcinoma of the stomach\* or gastroesophageal (GE) junction * GE junction tumors include esophageal tumors arising 5 cm from the anatomic GE junction or in the gastric cardia * Locally advanced (i.e., unresectable) or metastatic disease NOTE: \*Gastric stratum temporarily closed to accrual as of 03/01/2003 * Unidimensionally measurable disease * Target lesion must not be in previously irradiated field unless there is documentation of clear progression * No known brain metastases PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Zubrod 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT or SGPT no greater than 1.5 times ULN (5 times ULN if liver metastases present) Renal: * Creatinine no greater than 2 times ULN Cardiovascular: * No recent myocardial infarction * No unstable angina * No life-threatening arrhythmia Gastrointestinal: * No gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation * No active peptic ulcer disease * Must be able to swallow and/or receive enteral medications via gastrostomy feeding tube * No intractable nausea or vomiting Ophthalmic: * No history of corneal disease, including: * Dry eye syndrome or Sjögren's syndrome * Keratoconjunctivitis sicca * Exposure keratopathy * Fuch's dystrophy * Other active disorders of the cornea Other: * HIV negative * No active or uncontrolled infection * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission * No severe psychiatric disorders * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior biologic therapy * No concurrent anticancer immunotherapy Chemotherapy: * No prior chemotherapy for advanced or metastatic gastric cancer * At least 8 weeks since prior adjuvant chemotherapy or chemotherapy given as a radiosensitizer and recovered * No concurrent anticancer chemotherapy Endocrine therapy: * No concurrent anticancer hormonal therapy Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent anticancer radiotherapy Surgery: * At least 4 weeks since prior surgical procedure for stomach\* or GE cancer and recovered * No prior surgical procedures that would affect absorption NOTE: \*Gastric stratum temporarily closed to accrual as of 03/01/2003 Other: * No prior investigational drugs * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer therapy
References
Publications (2)
- RESULTDragovich T, McCoy S, Fenoglio-Preiser CM, Wang J, Benedetti JK, Baker AF, Hackett CB, Urba SG, Zaner KS, Blanke CD, Abbruzzese JL. Phase II trial of erlotinib in gastroesophageal junction and gastric adenocarcinomas: SWOG 0127. J Clin Oncol. 2006 Oct 20;24(30):4922-7. doi: 10.1200/JCO.2006.07.1316. PMID 17050876
- RESULTDragovich T, McCoy S, Urba SG, et al.: SWOG 0127: phase II trial of erlotinib in GEJ and gastric adenocarcinomas. [Abstract] American Society of Clinical Oncology 2005 Gastrointestinal Cancers Symposium, 27-29 January 2005, Miami, Florida. A-49, 2005.