Overview

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced or Metastatic Cancer of the Esophagus

Status:
Completed
Trial end date:
2007-01-01
Target enrollment:
0
Participant gender:
All
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than on drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients with advanced or metastatic cancer of the esophagus.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Fluorouracil
Paclitaxel
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed, newly diagnosed locally advanced
adenocarcinoma or squamous cell carcinoma of the esophagus Evidence of disease extension
into or through the wall of the esophagus (T2- T4) and/or regional nodal metastases (N1)
Patients with distant metastatic disease or who cannot undergo resection may also be
treated on the phase I portion of this trial but are not eligible for the modified phase II
portion Patients entered in the modified phase II portion of the trial must have evaluable
(measurable in one dimension) or measurable disease at the primary site

PATIENT CHARACTERISTICS: Age: 18 or over Performance status: ECOG 0-2 Life expectancy:
Greater than 2 months for those with metastatic disease or 2 years for those with locally
advanced disease Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3
Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 2.0 mg/dl Renal: Creatinine
clearance at least 60 mL/min Serum creatinine no greater than 1.5 mg/dL Cardiovascular: No
history of refractory congestive heart failure or cardiomyopathy Other: Not pregnant No
other malignancy within 5 years except: Curatively treated carcinoma in situ of the cervix
Basal cell carcinoma of the skin

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery:
More than 1 week since major surgery