Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery

OBJECTIVES:

Primary

• Determine the local tumor-control rate in patients with locally advanced, unresectable esophageal cancer treated with docetaxel, cisplatin, and radiotherapy.

Secondary

• Determine the feasibility of this regimen in these patients.
• Determine the adverse reactions of this regimen in these patients.
• Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen.
• Determine overall survival of patients treated with this regimen.
• Determine the long-term survival rate in patients treated with this regimen.
• Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen.
• Determine quality of life and clinical benefit in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1, 22, 43, 50, 57, 64, and 71. Beginning on day 43 (week 7) of chemotherapy, patients undergo radiotherapy once daily, 5 days a week, for 7 weeks.

Quality of life is assessed at baseline, at day 22 and 43 during treatment, and then every 3 months for 1 year after completion of study treatment.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed esophageal cancer, including the gastroesophageal junction

• Squamous cell or adenocarcinoma
• Unresectable disease
• Meets 1 of the following staging criteria by endoscopic ultrasound:

• Cervical (supraclavicular) lesion, meeting 1 of the following stages:

• TX, N+ disease
• T3-4, NX disease
• TX, NX, M1a* disease
• Thoracic (celiac) lesion, meeting 1 of the following stages:

• Unresectable T4, NX disease
• TX, NX, M1a* disease
• Locally advanced resectable tumors, inoperable due to medical reasons NOTE: *M1a requires unequivocal abnormality on staging CT scan/endosonography
• No T1-2, N0 disease
• All tumors encompassable in 1 radiation field
• No tumor with esophagotracheal fistula

PATIENT CHARACTERISTICS:

Performance status

• WHO 0-1

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• AST ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin normal
• Alkaline phosphatase ≤ 2.5 times ULN

Renal

• Creatinine clearance > 60 mL/min

Cardiovascular

• No myocardial infarction within the past 3 months
• No New York Heart Association class III or IV congestive heart failure
• No unstable angina pectoris
• No significant arrhythmias
• No other severe cardiovascular disease

Immunologic

• No uncontrolled active infection
• No active autoimmune disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 12 months after completion of study treatment
• No definite contraindication to corticosteroids
• No uncontrolled diabetes mellitus
• No pre-existing peripheral neuropathy > grade 1
• No significant neurologic or psychiatric disorder, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
• No other serious underlying medical condition that would preclude study participation
• No other prior or concurrent malignancy except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

Radiotherapy

• No prior radiotherapy to the chest

Other

• More than 30 days since prior experimental treatment in another clinical trial
• No other concurrent experimental drugs