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: December 5, 2012
Last verified: December 2012
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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.
| 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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045526
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center at Suffolk | |
| Commack, New York, United States, 11725 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | David Ilson | Memorial Sloan-Kettering Cancer Center at Suffolk |
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, N01CM62206, CDR0000256601 |
| Study First Received: | September 6, 2002 |
| Last Updated: | December 5, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Squamous Cell Esophageal Diseases Esophageal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell |
Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013