Taxotere, Cisplatin and Irinotecan (CPT-11) for Esophagogastric Cancer

Inclusion Criteria:

• Histologically confirmed, incurable esophageal or gastric carcinoma (carcinoma = adenocarcinoma or squamous cell carcinoma)
• Measurable disease > 1cm (longest diameter) by spiral CT scan or > 2cm by other radiographic technique.
• Lesions must be measurable in at least one dimension.
• Bone lesions, ascites and effusions are not measurable.
• Irradiated lesions are not measurable yet lesions arising in previously irradiated fields are measurable.
• Age 18+ years.
• ECOG performance status 0 or 1.
• Life expectancy greater than 12 weeks.
• Adequate bone marrow function.
• Adequate renal function: creatinine equal to or less than 1.5 mg/dl.
• SGOT less than 2.5 x institutional upper limit of normal if alkaline phosphatase is within institutional upper limit of normal.
• Alkaline phosphatase less than 4.0 x upper limit of normal if SGOT is within institutional upper limit of normal.
• For patients with both SGOT and alkaline phosphatase elevations, SGOT must be less than 1.5 x institutional upper limit of normal and alkaline phosphatase must be less 2.5 x institutional upper limit of normal. For patients with liver metastases, however, SGOT may be < 3.0 x institutional upper limit of normal and alkaline phosphatase may be < 5.0 x institutional upper limit of normal as long as the total bilirubin is within the institutional upper limit of normal.

Exclusion Criteria:

• No prior chemotherapy (except as part of pre- or post-operative therapy, completed > 1 year prior to start date of this protocol).
• Patients who have received prior pelvic radiation therapy are ineligible. Other prior radiation therapy, however, is permitted, provided at least 4 weeks have elapsed since completion of this therapy and the initiation of this protocol.
• No myocardial infarction in the past six months.
• No major surgery in the past three weeks.
• No uncontrolled serious medical or psychiatric illness.
• No uncontrolled diarrhea.
• Patients with a peripheral neuropathy > grade 1 will be excluded.
• Women of childbearing potential must have a negative pregnancy test. Men and women of childbearing potential must use adequate contraception.
• No clinically apparent central nervous system metastases or carcinomatous meningitis.
• No other active malignancy other than non-melanoma skin cancer or in-situ cervical carcinoma. A resected cancer (other than in-situ carcinoma) must have demonstrated no evidence of recurrence for at least 3 years.
• Patients with history of severe hypersensitivity to irinotecan, cisplatin, taxotere or drugs formulated with polysorbate 80 must be excluded.