A Phase II Study of Gemcitabine Plus Irinotecan (CPT-11) In Patients With Esophageal Cancer.

Histologic diagnosis of squamous cell carcinoma or adenocarcinoma of the esophagus or GE junction that is either metastatic or recurrent. No prior treatment for metastatic or recurrent disease. Prior chemotherapy and/or radiation therapy allowed if administered in the adjuvant or neoadjuvant setting at the time of initial diagnosis with localized disease. No gemcitabine or irinotecan as part of the chemotherapy. At least 28 days must have elapsed since completion of any other previous treatment; patients must have recovered from all toxicities. Prior thoraco-abdominal surgery allowed. Patients must be at least 21 days beyond surgery and recovered from all effects of surgery. Adequate renal function. No active inflammatory bowel disease, significant bowel obstruction or chronic diarrhea. No uncontrolled hypertension, unstable angina, symptomatic congestive heart failure, myocardial infarction within previous 6 months or serious uncontrolled cardiac arrhythmia. No known brain metastases, brain imaging studies (if done) must be negative. No active infection requiring systemic therapy. No other prior malignancy allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which patient is currently in complete remission, or any other cancer from which patient has been disease-free for 5 years.