taxotere, cisplatin and irinotecan (cpt-11) for esophagogastric cancer

Conditions: Esophageal Cancer; Gastric Cancer; GE Junction Cancer

Summary: this is a phase ii study of taxotere, cisplatin and irinotecan (cpt-11) used in combination to treat metastatic esophageal and gastric cancer in an effort to see what effects (good and bad) the combination may have on the patients cancer.

* taxotere, cisplatin and irinotecan will be administered to the patient once weekly for 2 weeks followed by a one week rest period (1 cycle is 3 weeks). * patients will also receive corticosteroids, intravenous hydration and anti-emetic therapy prior to each treatment. * a physical exam and bloodwork will be done each week of the treatment and every 2 cycles, reassessment of the tumor by the same imaging method to determine the baseline size will be conducted. * patients will remain on the study unless disease progression or intolerable toxicity occur.

Eligibility criteria:
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.

Keywords: esophageal cancer gastric cancer ge junction cisplatin taxotere cpt-11 irinotecan