Status:
COMPLETED
Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery
Lead Sponsor:
University of Miami
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, floxuridine, docetaxel, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping...
Detailed Description
OBJECTIVES: Primary * Determine whether neoadjuvant chemotherapy comprising oxaliplatin, floxuridine, docetaxel, and leucovorin calcium improves the rate of pathologic complete response in patients ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of adenocarcinoma of the esophagus meeting the following criteria:
- Stage II or III disease
- Resectable disease
- Previously untreated disease
- No stage I (mucosal only) or stage IV (metastatic) disease
- PATIENT CHARACTERISTICS:
- WBC \> 3,000/mm\^3
- Absolute neutrophil count \> 1,500/mm\^3
- Platelet count \> 100,000/mm\^3
- Creatinine ≤ 2.0 mg/dL
- Bilirubin \< 2 times normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have central venous access
- No other malignancy within the past 5 years
- No concurrent medical or psychiatric problem that would preclude study treatment
- No contraindications to paclitaxel
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy to the esophagus
- No oral cryotherapy (e.g., ice chips) on day 1 of each course
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00448760
Start Date
October 1 2004
End Date
April 1 2010
Last Update
February 7 2017
Active Locations (1)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136