A Phase II Study of Taxotere and Irinotecan (CPT-11) in Patients With Advanced Adenocarcinoma of the Lower Esophagus, Esophagogastric Junction, and Gastric Cardia

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the
lower esophagus, esophagogastric junction, or gastric cardia that is considered
unresectable and for which no curative therapy exists No other conventional forms of
therapy available that would offer a reasonable chance of cure or significant palliation
Gastric cardia is defined as no greater than 5 cm from the esophagogastric junction into
the stomach Measurable disease At least 1 lesion that can be accurately measured in at
least 1 dimension as at least 20 mm No nonmeasurable lesions only, including: Bone lesions
Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease
Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging
techniques Cystic lesions No known untreated or treated symptomatic CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no
greater than ULN (less than 2.5 times ULN if alkaline phosphatase no greater than ULN)
Alkaline phosphatase no greater than ULN (4 times ULN if AST no greater than ULN) Renal:
Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association
class III or IV heart disease Neurologic: No grade 2 or greater peripheral neuropathy of
any etiology No uncontrolled seizure disorder Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception Ability to complete
questionnaires alone or with assistance No uncontrolled infection No chronic debilitating
disease No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer or other noninvasive carcinoma

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy or biologic therapy for
recurrent or metastatic disease No concurrent biologic therapy No concurrent filgrastim
(G-CSF) as primary prophylaxis Chemotherapy: Prior adjuvant chemotherapy after complete
resection of original tumor allowed Prior neoadjuvant chemotherapy allowed No prior
chemotherapy for recurrent or metastatic disease No other concurrent chemotherapy
Endocrine therapy: Not specified Radiotherapy: Prior adjuvant radiotherapy after complete
resection of original tumor allowed Prior neoadjuvant radiotherapy allowed At least 4
weeks since prior radiotherapy No prior radiotherapy for recurrent or metastatic disease
No prior radiotherapy to more than 25% of bone marrow No concurrent radiotherapy except to
CNS Surgery: See Disease Characteristics Prior surgical resection of primary tumor allowed
At least 4 weeks since prior abdominal exploration with resection (3 weeks without
resection)