Status:
TERMINATED
Gefitinib in Treating Patients With Stage I, Stage II, or Stage III Esophageal Cancer That Can Be Removed By Surgery
Lead Sponsor:
University of Rochester
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Detailed Description
OBJECTIVES: Primary * Determine the safety and tolerability of neoadjuvant gefitinib in patients with resectable stage I-III esophageal cancer. Secondary * Determine the epidermal growth factor-re...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00258297
Start Date
April 1 2004
End Date
November 1 2006
Last Update
October 16 2013
Active Locations (1)
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1
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642