Overview

Combination Chemotherapy in Treating Patients With Previously Untreated Stage II or Stage III Esophageal Cancer That Can Be Removed By Surgery

Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
0
Participant gender:
All
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 them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with previously untreated stage II or stage III esophageal cancer that can be removed by surgery.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Miami
University of Miami Sylvester Comprehensive Cancer Center
Treatments:
Docetaxel
Floxuridine
Leucovorin
Oxaliplatin
Criteria
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