Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II

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