Erlotinib Hydrochloride in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00045526
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arm: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: erlotinib hydrochloride; Other: laboratory biomarker analysis	Phase 2

Detailed Description

PRIMARY OBJECTIVES:

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

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

3. 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study Of OSI-774 In Advanced Esophageal Cancer
• Study Start Date: Jun 1, 2002
• Actual Primary Completion Date: Feb 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment (erlotinib hydrochloride) Patients receive erlotinib hydrochloride PO QD. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.	Drug: erlotinib hydrochloride; Given PO; Other Names: CP-358,774 erlotinib OSI-774 ; Other: laboratory biomarker analysis; Correlative studies

Outcome Measures

Primary Outcome Measures

1. Major response rate (complete and partial response) [Up to 5 years]

Secondary Outcome Measures

1. Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [Up to 5 years]

2. Degree of dysphagia relief [Up to 5 years]

3. Time to progression [Up to 5 years]

   Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.

4. Overall survival [Up to 5 years]

   Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

• Principal Investigator: David Ilson, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT00045526
• Other Study ID Numbers: NCI-2012-01418; 02-035; NSC-718781; NCI-5445; CDR0000256601; MSKCC-02035; N01CM62206
• First Posted: Jan 27, 2003
• Last Update Posted: Jun 4, 2013
• Last Verified: Jun 1, 2013

• Additional relevant MeSH terms: Adenocarcinoma; Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Erlotinib Hydrochloride

Study Results

No Results Posted as of Jun 4, 2013