A Limited Access Phase II Trial of Cetuximab (C225, NSC #714692) in Combination With Cisplatin (NSC #119875) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 18
- 主要终点
- Tumor Response
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also help cisplatin work better by making tumor cells more sensitive to the drug. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving cetuximab together with cisplatin may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin works in treating patients with advanced, persistent, or recurrent cervical cancer.
详细描述
OBJECTIVES:
Primary
- Determine the antitumor activity of cetuximab and cisplatin, in terms of objective tumor response (partial and complete), in patients with advanced, persistent, or recurrent carcinoma of the cervix.
- Determine the nature and degree of toxicity of this regimen in these patients.
Secondary
- Determine the progression-free survival and overall survival of patients treated with this regimen.
- Correlate epidermal growth factor receptor expression with progression-free survival, overall survival, and response in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous or non-squamous cell carcinoma of the cervix
- •Advanced, persistent, or recurrent disease
- •Documented disease progression
- •Not amenable to curative therapy
- •Measurable disease
- •At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •At least 1 target lesion
- •Tumors within a previously irradiated field are designated as non-target lesions unless progression is documented or a biopsy is obtained ≥ 90 days after completion of radiotherapy to confirm persistence
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count ≥ 100,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST ≤ 2.5 times ULN
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No significant history of cardiac disease within the past 6 months, including the following:
- •Unstable angina
- •Uncontrolled hypertension
- •Uncontrolled congestive heart failure
- •Uncontrolled arrhythmia
- •No uncontrolled seizure disorder
- •No active neurological disease
- •No neuropathy (sensory and motor) > grade 1
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior anti-epidermal growth factor receptor (EGFR) antibody therapy
- •No prior chimerized or murine monoclonal antibody therapy
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •At least 1 week since prior anticancer hormonal therapy
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy
- •More than 30 days since prior major surgery, except diagnostic biopsy
- •Recovered from all prior therapy
- •No prior cytotoxic therapy for cervical cancer
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Tumor Response
时间窗: up to 6 months from study entry
Per GOG Response Evaluation Criteria In Solid Tumors(RECIST) Criteria: Complete Response(CR): disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response(PR): at least a 30% decrease in the sum of longest dimensions(LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of nontarget lesions and no new lesions. Increasing Disease: at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease: any condition not meeting the above criteria. Indeterminate for response: as having no repeat tumor assessments following initiation of study therapy for reasons unrelated to symptoms or signs of disease.
次要结局
- Progression-free Survival and Overall Survival at 6 Months After Completion of Treatment(up to 5 years from study entry)