OBJECTIVES:

• Determine the antitumor activity of irinotecan and paclitaxel in patients with metastatic or recurrent adenocarcinoma of the esophagus or stomach.
• Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis (adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia vs adenocarcinoma of the rest of the stomach).

Patients receive irinotecan IV over 90 minutes followed by paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 26-54 patients (13-27 per stratum) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the esophagus (including the gastroesophageal junction) or stomach

  • Inoperable metastatic or recurrent disease
  • Incurable with chemotherapy, radiotherapy, surgery, or combination therapy

• Bidimensionally measurable disease

  • At least 1 cm x 1 cm by CT scan or MRI
  • Mediastinal or hilar lymph nodes at least 2 cm in longest dimension by CT scan or MRI
  • No prior radiotherapy to only evaluable lesion
• No brain metastases
• No osseous metastasis as only site of disease

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-1

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 mg/dL
• SGOT no greater than 3 times upper limit of normal
• No known Gilbert's syndrome

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No unstable angina
• No myocardial infarction within the past 6 months
• No uncontrolled, clinically evident congestive heart failure

Other:

• No history of seizures
• No serious infection
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other disease that would preclude study
• No psychiatric disorders that would preclude study compliance
• No significant clinical neuropathy
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 4 weeks since prior immunotherapy and recovered
• No more than 1 prior immunotherapy regimen for metastatic disease
• No concurrent immunotherapy

Chemotherapy:

• See Disease Characteristics
• At least 4 weeks since prior chemotherapy and recovered
• No prior paclitaxel or irinotecan
• No more than 1 prior chemotherapy regimen for metastatic disease except fluorouracil as an adjuvant or radiosensitizer
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics
• At least 4 weeks since prior limited radiotherapy and recovered
• No prior radiotherapy to major bone marrow-containing areas (pelvis or lumbar spine)
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 1 week since prior minor surgery
• At least 3 weeks since prior major surgery
• Recovered from prior surgery

Other:

• At least 4 weeks since prior investigational therapy
• No concurrent phenytoin, phenobarbital, or other antiepileptic prophylaxis
• No other concurrent medication except analgesics, chronic treatments for concurrent medical conditions, or agents required for life-threatening medical problems
• No concurrent prochlorperazine on day of irinotecan administration