DX-8951f in Treating Patients With Metastatic Stomach Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study Of Intravenous Exatecan Mesylate (DX-891F) Administered Daily For Five Days Every Three Weeks To Patients With Previously Untreated Metastatic Gastric Cancer

Conditions
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Esophageal Cancer, Gastric Cancer

Intervention / Treatment
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* Drug: exatecan mesylate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: exatecan mesylate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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