Irinotecan and Paclitaxel in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus or Stomach

Exclusion Criteria

• •Patients who have received more than one prior chemotherapy regimen or immunotherapy for metastatic disease. Prior 5-FU alone as an adjuvant therapy or radiosensitizer is not counted. Patients must have an interval of 4 weeks from prior chemotherapy or immunotherapy with full recovery.
• •Patients receiving concurrent chemotherapy, immunotherapy, or radiotherapy.
• •Patients who are potentially curable with a chemotherapy, radiotherapy, surgery, or any combination of the above.
• •Patients with known brain metastases.
• •Patients with a history of seizures or are receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis.
• •Pregnant or lactating women. All women of childbearing potential must have a negative pregnancy test prior to entry into the study. All patients of procreative potential must be advised of the importance of avoiding pregnancy and using appropriate methods of contraception while participating in this investigational trial.
• •Patients with serious intercurrent infections, or any other concurrent disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
• •Patients with psychiatric disorders rendering them incapable of complying with the requirements of the protocol.
• •Patients with osseous metastasis as only site of disease.
• •Patients with any concurrent active malignancy other than non-melanoma skin cancers or carcinoma-in-situ of the cervix. Patients with previous malignancies but without evidence of disease for \> 5 years will be allowed to enter the trial.
• •Patients with known Gilbert's syndrome.
• •Patients who have a significant clinical neuropathy of greater than grade 2.
• •Patients with unstable angina, a history of myocardial infarction within the previous 6 months, or current clinical evidence of congestive heart failure. Patients taking medication for congestive heart failure and showing no clinical signs or symptoms are eligible.
• •Patients who have previously received a taxane or campthothecin
• •Patients who have received any investigational therapy within the previous 4 weeks.