Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Completed · Phase 2
Conditions studied: Adenocarcinoma of the Esophagus, Adenocarcinoma of the Gastroesophageal Junction, Recurrent Esophageal Cancer, Squamous Cell Carcinoma of the Esophagus, Stage III Esophageal Cancer, Stage IV Esophageal Cancer
In brief
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.
Key facts
- Study ID
- NCT00045526
- Run by
- National Cancer Institute (NCI)
- People needed
- 48
- Starts
- 2002-06-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
Full record on ClinicalTrials.gov
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