Status:
TERMINATED
Oxaliplatin, Gefitinib, and Radiation Therapy in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Gefitinib may stop the growth of tumor cells by blocki...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose of oxaliplatin when administered with gefitinib and radiotherapy in patients with locally advanced or metastatic adenocarcinoma or squamous...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus or gastroesophageal (GE) junction
- Locally advanced or metastatic disease by clinical staging, including esophagogastroduodenoscopy and esophageal ultrasound
- Stage T2, N0 disease and beyond
- Bulk of tumor must be in the esophagus of patients with GE junction tumor
- Bronchoscopy is required if primary esophageal tumor is \< 26 cm from the incisors
- No brain metastases
- PATIENT CHARACTERISTICS:
- Age
- Over 18
- Performance status
- ECOG 0-1
- Life expectancy
- At least 4 months
- Hematopoietic
- WBC ≥ 3,000/mm\^3
- Granulocyte count ≥ 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Hepatic
- Bilirubin normal
- ALT and AST ≤ 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2.5 times ULN
- Renal
- Not specified
- Cardiovascular
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Pulmonary
- No clinically active interstitial lung disease
- Patients with chronic stable asymptomatic radiographic changes are eligible
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method (including barrier) contraception during and for 3 months after study participation
- No peripheral neuropathy ≥ grade II
- No severe hypersensitivity to gefitinib or any of its excipients
- No history of allergy to platinum-based compounds or antiemetics administered with protocol-directed chemotherapy
- No active or ongoing infection
- No other uncontrolled illness
- No other significant clinical disorder or laboratory finding that would preclude study participation
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No concurrent colony-stimulating factors during course 1 of study therapy
- Chemotherapy
- More than 4 weeks since prior chemotherapy
- Endocrine therapy
- Concurrent steroid therapy allowed
- Radiotherapy
- More than 4 weeks since prior radiotherapy
- Surgery
- Not specified
- Other
- More than 30 days since prior non-approved or investigational drugs
- No concurrent administration of any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Barbiturates
- Highly-active antiretroviral therapy (HAART)
- Hypericum perforatum (St. John's wort)
- No other concurrent investigational agents or therapy
Exclusion
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00093652
Start Date
May 1 2003
Last Update
October 6 2015
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001