dx-8951f in treating patients with metastatic 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 exatecan mesylate in treating patients who have metastatic stomach cancer.

objectives: * determine the objective response rate of patients with previously untreated metastatic gastric cancer treated with exatecan mesylate (dx-8951f). * determine the time to tumor progression in this patient population when treated with this drug. * determine the survival at 6 and 12 months in this patient population when treated with this drug. * determine the quantitative and qualitative toxic effects of this drug in this patient population. * determine the pharmacokinetics of this drug in the plasma of these patients. outline: this is a multicenter study. patients receive exatecan mesylate (dx-8951f) iv over 30 minutes on days 1-5. treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months. projected accrual: a total of 12-37 patients will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically confirmed gastric or gastroesophageal adenocarcinoma * lymph node involvement and/or distant metastasis * no squamous cell carcinoma, small cell carcinoma, lymphoma, or leiomyosarcoma of the stomach * measurable disease with indicator lesions outside the field of prior radiotherapy * at least 20 mm by conventional scan or * at least 10 mm by spiral ct scan * nonmeasurable lesions include the following: * primary tumor * bone lesions * leptomeningeal disease * ascites * pleural/pericardial effusion * inflammatory breast disease * lymphangitis cutis/pulmonitis * cystic lesions * abdominal masses not confirmed and followed by imaging techniques * no prior treatment for locally advanced or metastatic disease * prior adjuvant treatment allowed if disease recurrence noted at least 6 months after completion of adjuvant treatment * no known brain metastases patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm3 * platelet count at least 100,000/mm3 * hemoglobin at least 9.0 g/dl hepatic: * bilirubin no greater than 2.0 mg/dl * ast or alt no greater than 2.5 times upper limit of normal (uln) (5 times uln if liver metastases present) * albumin at least 2.8 g/dl * pt or inr no greater than 1.5 times uln (coumadin independent) renal: * creatinine no greater than 1.5 mg/dl cardiovascular: * no active congestive heart failure * no uncontrolled angina * no myocardial infarction within the past 6 months other: * no concurrent serious infection * no other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * no overt psychosis, mental disability, or incompetence that would preclude informed consent * no other life-threatening illness * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: * see disease characteristics biologic therapy: * no concurrent anti-cancer biologic therapy * no concurrent prophylactic colony stimulating factors during first course of therapy chemotherapy: * recovered from prior adjuvant chemotherapy * no other concurrent anti-cancer chemotherapy * no other concurrent anti-cancer cytotoxic therapy endocrine therapy: * concurrent megestrol for appetite stimulation allowed radiotherapy: * at least 4 weeks since prior radiotherapy and recovered * no prior wide-field radiotherapy to more than 25% of bone marrow * no concurrent anti-cancer radiotherapy surgery: * at least 4 weeks since prior major surgery and recovered * no concurrent anti-cancer surgery other: * no other investigational drugs (including analgesics or antiemetics) for at least 4 weeks prior to, during, and for 4 weeks after study

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