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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00045526
First received: September 6, 2002
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicities, graded according to the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Degree of dysphagia relief [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method and confidence intervals will be formed for median time to progression.

  • Overall survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Estimated using the Kaplan-Meier method and confidence intervals will be formed for median survival time.


Estimated Enrollment: 48
Study Start Date: June 2002
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 10065
Sponsors and Collaborators
Investigators
Principal Investigator: David Ilson Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00045526     History of Changes
Other Study ID Numbers: NCI-2012-01418, 02-035, NSC-718781, NCI-5445, CDR0000256601, MSKCC-02035, N01CM62206
Study First Received: September 6, 2002
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Esophageal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014