Status:
COMPLETED
Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, eith...
Detailed Description
OBJECTIVES: Primary * Determine the activity of gefitinib, in terms of median survival and distant metastatic disease control, in patients treated with neoadjuvant and adjuvant cisplatin, fluorourac...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or large cell undifferentiated cancer of the esophagus or gastroesophageal junction
- T3, N1, or M1a disease only
- The following types are not allowed:
- Small cell undifferentiated carcinomas, lymphomas, or sarcomas
- Small cell or mixed small cell/non-small cell histology
- No evidence of distant hematogenous tumor metastases (M1b)
- No malignant pleural effusions
- PATIENT CHARACTERISTICS:
- Performance status
- ECOG 0-1
- Life expectancy
- Not specified
- Hematopoietic
- WBC \> 3,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Alkaline phosphatase \< 2 times normal
- AST \< 2 times normal
- No unstable or uncompensated hepatic disease
- Renal
- Creatinine ≤ 2.0 mg/dL
- Calcium normal
- No unstable or uncompensated renal disease
- Cardiovascular
- No unstable or uncontrolled angina
- No unstable or uncompensated cardiac disease
- Pulmonary
- See Disease Characteristics
- No limitations to pulmonary function that would preclude study participation
- No evidence of clinically active interstitial lung disease (asymptomatic patients with chronic stable radiographic changes are allowed)
- No unstable or uncompensated respiratory disease
- Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No evidence of severe or uncontrolled systemic disease
- No other uncontrolled malignancy
- No active infection
- No known severe hypersensitivity to gefitinib or any of its excipients
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior immunotherapy for this cancer
- Chemotherapy
- No prior chemotherapy for this cancer
- Radiotherapy
- No prior radiotherapy for this cancer
- Surgery
- Recovered from any prior oncologic or other major surgery
- No prior surgical resection for this cancer
- No concurrent ophthalmic surgery
- Other
- No prior photodynamic therapy for this cancer (prior laser treatments are acceptable)
- More than 30 days since prior unapproved or investigational drug
- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or Hypericum perforatum (St. John's wort)
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00258323
Start Date
October 1 2005
End Date
February 1 2010
Last Update
September 30 2015
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195