irinotecan in treating patients with esophageal or stomach cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of irinotecan in treating patients who have esophageal or stomach cancer.

objectives: i. determine the antitumor activity of irinotecan in patients with adenocarcinoma of the esophagus or gastric cardia. ii. evaluate the toxicities of this drug in this patient population. outline: this is a multicenter study. patients receive irinotecan intravenous (iv) over 90 minutes once a week for 4 weeks followed by a 2 week rest period. treatment continues in the absence of unacceptable toxicity or disease progression. patients are followed every 3 months until death. projected accrual: a total of 18-32 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * patients must be \> 18 years of age * patients must have a performance status of 0-2 on the eastern cooperative oncology group (ecog) performance scale * patients must have a predicted life expectancy of at least 12 weeks * patients must have a pretreatment granulocyte count of \>1500/mm3, a hemoglobin level of \>9.0 gm/dl and the platelet count of \>100000/mm3 * patients must have adequate renal function as documented by a serum creatinine \< 2.0 mg/dl * patients must have adequate hepatic function as documented by a serum bilirubin \< 1.5 mg/dl, regardless of whether patients have liver involvement secondary to tumor. aspartate transaminase must be \< 3 x institutional upper limit of normal unless the liver is involved with tumor, in which case the aspartate transaminase must be \< 5 x institutional upper limit of normal * patients must have histologically proven adenocarcinoma of the esophagus or gastric cardia with progression despite prior chemotherapy * patients must have disease radiologically measurable bidimensionally * patients must have an interval of 4 weeks from prior chemotherapy, immunotherapy, or radiation therapy exclusion criteria: * patients with any active or uncontrolled infection * patients with psychiatric disorders that would interfere with consent or follow-up * patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy * patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least five years * pregnant or lactating women. men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * presence of clinically apparent central nervous system metastases or carcinomatous meningitis * patients with uncontrolled diabetes mellitus * patients with any other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study * prior therapy with a deoxyribonucleic acid (dna) topoisomerase inhibitor * patients with known gilbert's syndrome

Keywords: stage i gastric cancer stage ii gastric cancer stage iii gastric cancer stage iv gastric cancer recurrent gastric cancer stage i esophageal cancer stage ii esophageal cancer stage iii esophageal cancer stage iv esophageal cancer recurrent esophageal cancer adenocarcinoma of the stomach adenocarcinoma of the esophagus