Status:
COMPLETED
Oxaliplatin, Capecitabine, and Radiation Therapy in Patients Undergoing Surgery for Stage II, III, IV Esophageal Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ra...
Detailed Description
OBJECTIVES: Primary * Determine the complete pathologic response (complete response \[CR\]) rate in patients with stage II-IVA esophageal cancer treated with neoadjuvant oxaliplatin, capecitabine, a...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of squamous cell carcinoma of the esophagus or adenocarcinoma of the esophagus
- Stage II-IVA disease as determined by clinical staging, including endoscopy and CT scan with or without endoscopic ultrasound
- Bulk of gastroesophageal junction tumor should be in the esophagus
- Bronchoscopy with biopsy and cytology required if primary esophageal cancer is \< 26 cm from incisors
- No known brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Life expectancy \> 4 months
- WBC \> 4,000/mm³
- ANC \> 1,500/mm³
- Platelet count \> 100,000/mm³
- Hemoglobin \> 9 g/dL
- Bilirubin normal
- Creatinine normal
- AST \< 2.5 times upper limit of normal (ULN)
- Alkaline phosphatase ≤ 3 times ULN
- Able to take oral medication or undergo enteral administration of medication
- No peripheral neuropathy ≥ grade 2
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 90 days after completion of study treatment
- No hypersensitivity to platinum compounds, fluoropyrimidines, or antiemetics administered in combination with protocol-directed chemotherapy
- No concurrent uncontrolled illness, including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would preclude study compliance
- No history of second malignancy except for curatively treated carcinoma in situ of the cervix or nonmelanoma skin cancer
- Other cured tumors allowed at discretion of the principal investigator
- No known HIV or hepatitis B or C (active and/or previously treated)
- PRIOR CONCURRENT THERAPY:
- No prior therapy for esophageal cancer
- No other concurrent investigational agents
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00470184
Start Date
November 1 2006
Last Update
November 25 2013
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001