Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI MSKCC-02035 NSC-718781, NCI-5445, NCT00045526, 5445

Objectives

1. Determine the objective response rate in patients with advanced carcinoma of the esophagus or gastroesophageal junction treated with erlotinib.
2. Determine the overall survival of patients treated with this drug.
3. Determine the degree of dysphagia relief in patients treated with this drug.
4. Determine the toxicity and tolerability of this drug in these patients.
5. Correlate epidermal growth factor receptor (EGFR) expression with response to treatment in these patients.

Entry Criteria

Disease Characteristics:

• 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 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

Prior/Concurrent Therapy:

Biologic therapy

• No prior cetuximab

Chemotherapy

• 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

Endocrine therapy

• Not specified

Radiotherapy

• See Chemotherapy
• At least 3 weeks since prior radiotherapy

Surgery

• See Chemotherapy

Other

• 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 HIV-positive patients

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 70-100%

Life expectancy

• More than 3 months

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)
• AST no greater than 2 times ULN

Renal

• Creatinine no greater than 1.5 mg/dL
• Calcium no greater than 12 mg/dL
• No symptomatic hypercalcemia

Cardiovascular

• No symptomatic congestive heart failure
• No unstable angina pectoris
• No ventricular arrhythmia

Other

• 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

Expected Enrollment

A total of 18-48 patients (9-24 per stratum) will be accrued for this study within 2 years.

Outcomes

Major response rate (complete and partial response)

Toxicity
Degree of dysphagia relief
Time to progression
Overall survival

Outline

This is a non-randomized study. Patients are stratified according to epidermal growth factor receptor status (positive vs negative).

Patients receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

David Ilson, MD, PhD, Protocol chair		Ph: 212-639-8306; 800-525-2225

Registry Information
Official Title		Phase II Study Of OSI-774 In Advanced Esophageal Cancer
Trial Start Date		2002-06-27
Registered in ClinicalTrials.gov		NCT00045526
Date Submitted to PDQ		2002-07-09
Information Last Verified		2005-10-21
NCI Grant/Contract Number		CA17105, CM17105

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