S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction
• •* Squamous cell carcinoma OR
• •* Adenocarcinoma
• •No known brain metastases
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 to 100
• •Performance status:
• •Zubrod 0-2
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Granulocyte count at least 1,500/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Hepatic:
• •Not specified
• •Renal:
• •Creatinine no greater than 1.5 times upper limit of normal
• •Cardiovascular:
• •No uncontrolled hypertension
• •No unstable angina
• •No symptomatic congestive heart failure
• •No myocardial infarction within the past 6 months
• •No serious uncontrolled cardiac arrhythmia
• •Gastrointestinal:
• •No active inflammatory bowel disease
• •No significant bowel obstruction
• •No chronic diarrhea
• •Other:
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No active infection requiring systemic therapy
• •No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •At least 28 days since prior biologic therapy
• •No prior biologic therapy for metastatic or recurrent disease
• •No concurrent sargramostim (GM-CSF)
• •No concurrent immunotherapy for tumor
• •Chemotherapy:
• •At least 28 days since prior chemotherapy
• •No prior chemotherapy for metastatic or recurrent disease
• •No prior gemcitabine or irinotecan
• •Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed
• •No other concurrent chemotherapy for tumor
• •Endocrine therapy:
• •See Disease Characteristics
• •At least 28 days since prior endocrine therapy
• •No prior endocrine therapy for metastatic or recurrent disease
• •No concurrent hormonal therapy for tumor
• •Radiotherapy:
• •At least 28 days since prior radiotherapy
• •No prior radiotherapy for metastatic or recurrent disease
• •Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed
• •No concurrent radiotherapy for tumor
• •Surgery:
• •Prior thoraco-abdominal surgery allowed
• •At least 3 weeks since prior surgery and recovered
• •Other:
• •No other concurrent anti-cancer therapy for tumor