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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy. Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Cisplatin; Docetaxel

Criteria

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