Esophageal Cancer Clinical Trial
DX-8951f in Treating Patients With Metastatic Stomach 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.
Full Description
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
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There are 6 Locations for this study
Long Beach California, 90813, United States
Denver Colorado, 80218, United States
Dallas Texas, 75235, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Hamilton Ontario, L8V 5, Canada
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