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

NCT00268346 | Completed Phase 2 Results DMC

• 4 other identifiers: CCF5538P30CA043703CCF-5538ZENECA-1839IL/0234
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

adenocarcinoma of the esophagus; recurrent esophageal cancer; squamous cell carcinoma of the esophagus; stage IV esophageal cancer

Outcome Measures

Primary Outcomes (1)

• The Number of Patients With Complete or Partial Response Rate of Single Agent ZD1839 in a Patient Population With Recurrent or Metastatic Cancer of the Esophagus or Gastroesophageal Junction, Using the RECIST 1.0 Criteria.

  The overall response is the number of patients with the best response recorded in measurable disease (target lesions) from start to disease progression.Complete response is the number of patients with the disappearance of all target lesions. Partial response is the number of patients with larger than or equal to 30% decrease in sum of the longest diameters from baseline. Progressive disease is larger than or equal to 20% increase in sum of the longest diameters over the smallest sum observed or appearance of new lesions. Stable disease is neither PR nor PD criteria met.

  at 8 weeks after initiation of treatment

Study Arms (1)

ZD1839

EXPERIMENTAL

Drug: ZD1839

Interventions

ZD1839 DRUG

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

Also known as: IRESSA®, Gefitinib

ZD1839

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed squamous cell carcinoma, adenocarcinoma, or large-cell undifferentiated carcinoma of the esophagus or gastroesophageal junction * Patients must have disease that is either metastatic (i.e., M1b by the definitions of the American Joint Committee on Cancer 1997 staging system) or recurrent after definitive therapy, and must be considered incurable by conventional treatments * Patients with small cell, or mixed small cell/non-small-cell histology are ineligible * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: David Adelstein MD
• Organization: Cleveland Clinic Taussig Cancer Institute

adelstd@ccf.org

216-444-9310

Study Officials

• David J. Adelstein, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2005
• First Posted: December 22, 2005
• Study Start: October 1, 2005
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2011
• Last Updated: January 5, 2016
• Results First Posted: March 16, 2012

Record last verified: 2015-12

Locations

US (1)