Gefitinib in Treating Patients With Recurrent or Metastatic Esophageal or Gastroesophageal Junction Cancer

NCT ID: NCT00268346

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2011-08-31

Brief Summary

RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with recurrent or metastatic esophageal or gastroesophageal junction cancer.

Detailed Description

OBJECTIVES:

Primary

• Explore the activity of single agent gefitinib, in terms of response rate, in a patient population with recurrent or metastatic esophageal or gastroesophageal junction cancer.

Secondary

• Assess the toxicity of this drug in these patients.

OUTLINE: Patients are stratified according to prior treatment (yes vs no).

Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study.

Conditions

Esophageal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ZD1839

Group Type: EXPERIMENTAL

ZD1839

Intervention Type: DRUG

ZD1839 treatment will be taken once a day PO, every day about the same time

Interventions

ZD1839

ZD1839 treatment will be taken once a day PO, every day about the same time

Intervention Type: DRUG

Other Intervention Names

IRESSA®; Gefitinib

Eligibility Criteria

Inclusion Criteria

• Patients with lymphoma or sarcoma are also ineligible
• Disease must be measurable in at least one dimension by physical exam, x-ray, CT scan or MRI, ultrasound, or endoscopy

• Measurable disease can be a previously irradiated lesion if disease growth has been documented in the lesion since completion of radiation therapy
• An elevation in carcinoembryonic antigen (CEA) is not sufficient to use by itself in response assessment

PATIENT CHARACTERISTICS:

• ECOG Performance Status 0-1
• WBC ≥ 3,000/mm^3
• Platelet count ≥ 100,000/mm^3
• Creatinine ≤ 2.0 mg/dL
• Alkaline phosphatase and AST < twice normal
• Bilirubin < twice normal
• Calcium normal
• No known severe hypersensitivity to study drug or any of its excipients
• No clinical evidence of any other uncontrolled malignancy except adequately treated basal or squamous cell skin cancer or in situ cervical cancer
• Pregnant or nursing women are ineligible
• Fertile patients must use effective contraception
• No evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
• No evidence of clinically active interstitial lung disease

• Patients with chronic stable radiographic changes who are asymptomatic need not be excluded

PRIOR CONCURRENT THERAPY:

• Patients may not have received more than one previous systemic treatment regimen

• Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease
• Previously untreated patients are also eligible
• No previous treatment with study drug or any other epidermal growth factor receptor (EGFR) antagonists
• More than 30 days since prior treatment with a non-approved or investigational drug
• At least 4 weeks must have elapsed since any surgery, radiation therapy, or chemotherapy administration
• Recovered from previous oncologic or other major surgery
• No concurrent barbiturates (e.g., phenytoin), carbamazepine, rifampicin, phenobarbital or Hypericum perforatum (St. John's wort)
• No concurrent surgery, radiation therapy, hormonal therapy, or other chemotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

David Adelstein, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David J. Adelstein, MD

Role: STUDY_CHAIR

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCF-5538

Identifier Type: OTHER

Identifier Source: secondary_id

ZENECA-1839IL/0234

Identifier Type: -

Identifier Source: secondary_id

CCF5538

Identifier Type: -

Identifier Source: org_study_id