NCT00025142已完成2 期
A Study of ZD1839 (Iressa) in Combination With Oxaliplatin, 5-Fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Malignancies (Phase I) and Advanced Colorectal Cancers (Phase II)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Biological therapies such as gefitinib may interfere with the growth of tumor cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug with gefitinib may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of gefitinib and oxaliplatin combined with leucovorin and fluorouracil in treating patients who have advanced solid tumors or colorectal cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of gefitinib and oxaliplatin when combined with fluorouracil and leucovorin calcium in patients with advanced solid tumors. (Phase I) (Phase I closed as of 5/30/02)
- Determine the pharmacokinetics and pharmacodynamics of this regimen in these patients.
- Determine the dose-limiting toxic effects and other toxic effects of this regimen in these patients.
- Determine the antitumor response in patients with advanced colorectal adenocarcinoma treated with this regimen. (Phase II)
- Determine the overall survival and time to progression in patients with advanced colorectal adenocarcinoma treated with this regimen. (Phase II)
- Determine the presence of polymorphisms or other genetic alterations in genes implicated in the action of this regimen and determine their possible relationship with toxic effects of and antitumor response to this regimen in these patients.
OUTLINE: This is a dose-escalation study of gefitinib and oxaliplatin (L-OHP).
- Phase I (closed as of 5/30/02): Patients receive L-OHP IV over 2 hours on day 1 and leucovorin calcium (CF) IV over 2 hours followed by fluorouracil (5-FU) IV bolus and 5-FU IV over 22 hours on days 1 and 2 during all courses. Beginning with course 2, patients also receive oral gefitinib daily on days 1-14. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses past CR.
Sequential dose escalation of gefitinib is followed by sequential dose escalation of L-OHP. Cohorts of 3-6 patients receive escalating doses of gefitinib and L-OHP until the maximum tolerated dose (MTD) of the combination is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
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:
- •Phase I (closed as of 5/30/02):
- •Histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective
- •Phase II:
- •Histologically confirmed metastatic or unresectable colorectal adenocarcinoma
- •Measurable disease or assessable but nonmeasurable disease (including ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT scan/MRI), or cystic lesions)
- •Disease characterized only by elevated serum tumor marker allowed
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Life expectancy:
- •More than 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm ^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST/ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No ongoing or active infection
- •No peripheral neuropathy
- •No prior allergic reactions to compounds of similar chemical or biologic composition to gefitinib or other study agents
- •No other concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No prior bone marrow or stem cell support with high-dose chemotherapy
- •At least 24 hours since prior colony-stimulating growth factors
- •Chemotherapy:
- •See Biologic therapy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No more than 3 prior chemotherapy regimens
- •Endocrine therapy:
- •At least 2 weeks since prior hormonal therapy except megestrol for anorexia/cachexia
- •Radiotherapy:
- •No prior pelvic or whole abdominal radiotherapy
- •At least 4 weeks since other prior radiotherapy and recovered
- •At least 4 weeks since prior major surgery (e.g., laparotomy) and recovered
- •At least 4 weeks since prior investigational therapy
- •No other concurrent investigational or commercial anticancer agents
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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