Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Esophageal Cancer

• Status: Completed
• Trial end date: 2004-04-01
• 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 chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have advanced cancer of the esophagus.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction

• T1, N1, M0 or T2-4, Nx, M0

• No supraclavicular or celiac lymph nodes

• Previously untreated, newly diagnosed tumors OR

• Prior resection without adjuvant therapy with local regional failure

• Positive microscopic margin on resection of all gross disease allowed provided no metastatic disease

• No positive malignant cytology of the pleura, pericardium, or peritoneum

• No biopsy proven tumor invasion of the tracheobronchial tree or tracheoesophageal fistula

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100% OR

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count greater than 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 9.0 g/dL

Hepatic:

• Bilirubin no greater than 1.5 mg/dL

• No known Gilbert's disease

Renal:

• Creatinine no greater than 1.5 mg/dL

• No hypercalcemia

Cardiovascular:

• No New York Heart Association class III or IV heart disease

• No myocardial infarction within the past 6 months

• No uncontrolled hypertension

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other severe concurrent conditions (e.g., severe uncontrolled diabetes, uncontrolled infections, or cerebral vascular disease)

• No other malignancy within the past 5 years except basal cell carcinoma of the skin or carcinoma in situ of the cervix

• No history of seizure disorder currently receiving phenytoin, phenobarbital, or other antiepileptic medication

• No other concurrent medical or psychiatric condition or disease that would preclude study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for esophageal cancer including adjuvant chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy for esophageal cancer including adjuvant radiotherapy

• No prior mantle, chest, pelvic, or hemibody radiotherapy

Surgery:

• See Disease Characteristics

Other:

• No concurrent prochlorperazine on day of irinotecan administration