Clinical trial NCT00045526: Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
Official title: Phase II Study Of OSI-774 In Advanced Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib (erlotinib hydrochloride).

II. Determine the overall survival of patients treated with this drug. III. Determine the degree of dysphagia relief in patients treated with this drug.

IV. Determine the toxicity and tolerability of this drug in these patients. V. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients.

OUTLINE:

Patients receive erlotinib hydrochloride orally (PO) once daily (QD). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility criteria: 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

Primary outcomes:
measure: Major response rate (complete and partial response)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC)
timeFrame: Up to 5 years
measure: Degree of dysphagia relief
timeFrame: Up to 5 years
measure: Time to progression
timeFrame: Up to 5 years
measure: Overall survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Ilson
role: PRINCIPAL_INVESTIGATOR
References: