Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery

NCT00258297 | Terminated Phase 2 DMC

• 3 other identifiers: CDR0000447159URCC-U2203ZENECA-1839US/0282
• Study Type: interventional
• Target: 30
• 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. Giving gefitinib before surgery may shrink the tumor so that it can be removed. PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with stage I, stage II, or stage III esophageal cancer that can be removed by surgery.

Conditions

Esophageal Cancer

Keywords

stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; adenocarcinoma of the esophagus; squamous cell carcinoma of the esophagus

Outcome Measures

Primary Outcomes (1)

• Effect on the signaling pathways by immunohistochemistry after 2-3 weeks of exposure to gefitinib

Interventions

gefitinib DRUG

conventional surgery PROCEDURE

enzyme inhibitor therapy PROCEDURE

neoadjuvant therapy PROCEDURE

protein tyrosine kinase inhibitor therapy PROCEDURE

surgery PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell or adenocarcinoma of the thoracic esophagus * Resectable, localized disease with or without metastases in local lymph nodes (T1, T2, or T3; any N; M0) * Stage I-III disease * No known distant metastases * No cervical-esophageal tumors (upper border \< 18 cm from the incisor teeth) * No supraclavicular metastases PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Adequate bone marrow function Hepatic * Adequate hepatic function * No unstable or uncompensated hepatic disease Renal * Creatinine ≤ grade 2 by Common Toxicity Criteria * Adequate renal function * No unstable or uncompensated renal disease Cardiovascular * No unstable or uncompensated cardiac disease Pulmonary * No clinically active interstitial lung disease unless it is asymptomatic with chronic stable radiographic changes * No unstable or uncompensated respiratory disease Other * Not pregnant or nursing * Fertile patients must use effective contraception * No known hypersensitivity to gefitinib or any of the excipients * No other malignancy within the past 2 years except basal cell carcinoma or carcinoma in situ of the cervix * No evidence of severe or uncontrolled systemic disease * No other significant clinical disorder or laboratory finding that would preclude study participation PRIOR CONCURRENT THERAPY: Endocrine therapy * Concurrent stable-dose steroids allowed Surgery * Recovered from any prior oncologic or other major surgery Other * More than 30 days since prior nonapproved or investigational drug * No prior therapy for this or any other malignancy * No concurrent phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum (St. John's wort)

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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms; Adenocarcinoma Of Esophagus; Esophageal Squamous Cell Carcinoma

Interventions

Gefitinib; Neoadjuvant Therapy; Surgical Procedures, Operative

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; Combined Modality Therapy; Therapeutics

Study Officials

• Kishan J. Pandya, MD

  James P. Wilmot Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: April 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)