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About
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. Irinotecan may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Irinotecan and docetaxel may also make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with irinotecan and radiation therapy with or without cisplatin in treating patients with locally advanced esophageal cancer.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive one of the following regimens. Regimen 2 is for patients recruited after the recommended phase II dose has been determined in patients recruited (who receive regimen 1).
Regimen 1:
Regimen 2:
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed squamous cell carcinoma, adenocarcinoma, poorly differentiated carcinoma, or carcinoma not otherwise specified, of the esophagus or gastroesophageal (GE) junction
Disease clinically limited to the esophagus or GE junction (T1, N1, M0, or T2-4, any N, M0)
M1a metastatic disease to lymph nodes allowed
Disease must be able to be contained in a radiotherapy field
Previously untreated patients with primary tumors of the cervical or thoracic esophagus, including the GE junction, are eligible for this study
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
Pre-existing peripheral neuropathy > grade 1
Severe comorbid conditions including, but not limited to, any of the following:
Pregnant or lactating women
History of prior malignancy diagnosed and/or treated within the past three years, except for basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder
Known Gilbert disease
History of seizure disorder with concurrent phenytoin, phenobarbital, or other antiepileptic medication
Any other concurrent medical or psychiatric condition or disease that, in the investigator's judgment, would make the patient inappropriate for entry into this study
Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with the requirements
PRIOR CONCURRENT THERAPY:
Primary purpose
Allocation
Interventional model
Masking
27 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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