NCT00017212已完成2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 6
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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:
- •18 and over
- •Performance status:
- •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
- •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)
- •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
- •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:
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (6)
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