A Phase II Trial of Preoperative Irinotecan, Cisplatin and Radiation in Esophageal Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed carcinoma of the esophagus or
gastroesophageal junction of 1 of the following subtypes:

- Squamous cell carcinoma (closed to accrual as of 04/19/10)

- Adenocarcinoma

- Poorly differentiated carcinoma

- Carcinoma not otherwise specified

- Meets 1 of the following stage criteria:

- T2-4, N0-1, M0 disease by endoscopic ultrasound (EUS)

- T1 tumors allowed if they are T1, N1, M0

- Regional thoracic lymph node involvement (N1) is allowed

- No in situ carcinoma

- No clinical involvement of supraclavicular or celiac lymph nodes by EUS, CT
scan, or PET scan unless proven to be false positive by biopsy

- Meets the following criteria regarding extent of disease:

- Disease must be clinically limited to the esophagus or gastroesophageal
junction*

- If the tumor extends below the gastroesophageal junction into the proximal
stomach, 50% of the tumor must involve the distal esophagus or gastroesophageal
junction* NOTE: *Adenocarcinomas of the distal esophagus include tumors of the
distal esophagus, or Siewert type I; tumors of the gastroesophageal junction
which involve, equally, both the distal esophagus and proximal stomach or
Siewert type II

- Tumor must be surgically resectable

- No cervical esophageal tumors

- No gastric cancers with minor involvement of the gastroesophageal junction or distal
esophagus

- No tracheoesophageal fistulas

- No evidence of metastatic disease, including either of the following:

- Positive malignant cytology of the pleura, pericardium, or peritoneum

- Radiographic evidence of distant organ involvement, including lung, liver, bone,
or brain

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 9 g/dL

- Creatinine normal

- Bilirubin ≤ 1.5 mg/dL

- FEV_1 and pulmonary function test ≥ 1.2 liters OR ≥ 35% of normal

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of clinically significant ventricular arrhythmia requiring ongoing
medication with antiarrhythmic drugs

- No myocardial infarction within the past 6 months

- No angina

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

- No history of active seizure disorder

- No clinically significant hearing loss

- No known Gilbert's disease.

- No evidence of recurrent laryngeal nerve or phrenic nerve paralysis

- No prior malignancies except basal cell or squamous cell skin cancer, carcinoma in
situ of the cervix, superficial transitional cell bladder carcinoma, or other cancer
for which the patient has been disease free for at least 3 years

PRIOR CONCURRENT THERAPY:

- At least 4 weeks since prior major surgery

- Recovered from the effects of minor surgery (including laparoscopy or thoracoscopy)

- No prior chemotherapy

- No prior radiotherapy

- No ongoing treatment with phenytoin, phenobarbital, or other antiepileptic medication

- Valproic acid allowed

- No concurrent palliative radiotherapy

- No concurrent intensity-modulated radiotherapy

- No concurrent treatment with hormones or other chemotherapeutic agents except for the
following:

- Steroids for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes)

- Dexamethasone as an antiemetic prior to cisplatin therapy