Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing Surgery for Locally Advanced Esophageal Cancer

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, carboplatin, and capecitabine, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with carboplatin and capecitabine followed by chemoradiotherapy in treating patients who are undergoing surgery for locally advanced esophageal cancer.

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

Details

• Lead Sponsor: University of Washington
• Treatments: Capecitabine; Carboplatin; Docetaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed esophageal or gastroesophageal junction cancer

• Locally advanced disease, meeting 1 of the following staging criteria:

• T3, N0, M0 disease

• Any T, N1, M0 disease

• Measurable or evaluable disease

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 8.0 g/dL

Hepatic

• Bilirubin normal

• Meets 1 of the following criteria:

• Alkaline phosphatase (AP) normal AND AST/ALT ≤ 5 times upper limit of normal (ULN)

• AP ≤ 2.5 times ULN AND AST/ALT ≤ 1.5 times ULN

• AP ≤ 5 times ULN AND AST/ALT normal

Renal

• Creatinine ≤ 2.0 mg/dL

• Creatinine clearance ≥ 80 mL/min

Cardiovascular

• No uncontrolled congestive heart failure

• No symptomatic coronary artery disease

• No uncontrolled arrhythmias

• No myocardial infarction within the past 12 months

• No other uncontrolled clinically significant cardiac disease

Gastrointestinal

• Able to swallow tablets

• Intact upper gastrointestinal tract

• No malabsorption syndrome

Immunologic

• No history of unanticipated severe reaction to fluoropyrimidine

• No known hypersensitivity to fluorouracil

• No severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80

• No serious infection that requires continuous antibiotic therapy

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment

• No other prior or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

• No history of seizures

• No history of serious psychiatric illness that would preclude study compliance or giving informed consent

• No peripheral neuropathy > grade 1

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

Radiotherapy

• No prior radiotherapy

Other

• More than 28 days since prior investigational drugs

• No concurrent warfarin for active anticoagulation