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Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
This study has been completed.

First Received on September 6, 2002.   Last Updated on May 11, 2011   History of Changes
Sponsor: Memorial Sloan-Kettering Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045526
  Purpose

RATIONALE: Erlotinib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth.

PURPOSE: This phase II trial is studying erlotinib to see how well it works in treating patients with advanced esophageal cancer or stomach cancer.


Condition Intervention Phase
Esophageal Cancer
Drug: erlotinib hydrochloride
Phase II

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: Phase II Study Of OSI-774 In Advanced Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Major response rate (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Degree of dysphagia relief [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

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

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.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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/mm^3
  • Platelet count at least 100,000/mm^3

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045526

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: David H. Ilson, MD, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00045526     History of Changes
Other Study ID Numbers: CDR0000256601, MSKCC-02035, NSC-718781, NCI-5445
Study First Received: September 6, 2002
Last Updated: May 11, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the esophagus
recurrent esophageal cancer
squamous cell carcinoma of the esophagus
stage III esophageal cancer
stage IV esophageal cancer

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012