NCT00031993已完成2 期
A Phase II Evaluation Of OSI-774 (NSC #718781) In The Treatment Of Persistent or Recurrent Squamous Cell Carcinoma Of The Cervix
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This phase II trial is studying erlotinib to see how well it works in treating patients with persistent or recurrent cancer of the cervix. Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the antitumor cytostatic activity of OSI-774 as measured by the probability of surviving progression-free for at least 6 months in patients with persistent or recurrent squamous cell carcinoma of the cervix.
II. To determine the nature and degree of toxicity of OSI-774 in this cohort of patients.
SECONDARY OBJECTIVES:
I. To determine the partial and complete response rates in patients with squamous cell carcinoma of the cervix receiving OSI-774.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed squamous cell carcinoma (SCC) of the cervix
- •Persistent or recurrent progressive disease
- •At least 1 prior systemic chemotherapy regimen for management of advanced, metastatic, or recurrent SCC of the cervix is required
- •Chemotherapy administered as a radiosensitizer in conjunction with radiotherapy does not count as a systemic chemotherapy regimen
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Lesions within a previously irradiated field are considered nontarget lesions unless disease progression or persistence is confirmed ≥ 90 days after completion of radiotherapy
- •Tumor accessible for repeat needle biopsy
- •Ineligible for a higher priority Gynecologic Oncology Group (GOG) protocol (any active GOG phase III protocol for the same patient population)
- •Performance status - GOG 0-2 (for patients who have received only 1 prior regimen)
- •Performance status - GOG 0-1 (for patients who have received 2 prior regimens)
- •Platelet count at least 100,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.5 times ULN
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No abnormalities of the cornea (e.g., dry eye syndrome or Sjogren's syndrome)
- •No congenital abnormalities (e.g., Fuch's dystrophy)
- •No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- •No abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No uncontrolled concurrent illness
- •No ongoing or active infection requiring IV antibiotics
- •No psychiatric illness or social situation that would preclude study compliance
- •No grade 2 or greater sensory or motor neuropathy
- •No prior allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •HIV negative
- •At least 3 weeks since prior immunologic therapy for SCC of the cervix
- •One additional prior cytotoxic chemotherapy regimen for recurrent or persistent disease allowed
- •At least 3 weeks since prior chemotherapy for SCC of the cervix and recovered
- •No prior non-cytotoxic chemotherapy for recurrent or persistent disease
- •At least 3 weeks since prior hormonal therapy for SCC of the cervix
- •At least 3 weeks since prior radiotherapy for SCC of the cervix and recovered
- •Recovered from recent prior surgery
- •At least 3 weeks since other prior therapy for SCC of the cervix
- •No prior epidermal growth factor receptor-targeting therapies
- •No prior anticancer treatment that would preclude study participation
- •No other concurrent investigational or commercial agents or therapies for SCC of the cervix
排除标准
- 未提供
研究组 & 干预措施
Treatment (erlotinib hydrochloride)
Experimental
Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: erlotinib hydrochloride (Drug)
Treatment (erlotinib hydrochloride)
Experimental
Patients receive oral erlotinib once daily for 4 weeks. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Progression-free survival
时间窗: At 6 months
Frequency and severity of adverse effects as measured by NCI CTC version 3.0
时间窗: Up to 5 years
次要结局
- Duration of overall survival(Up to 5 years)
- Duration of progression-free survival(Up to 5 years)
- Frequency of clinical response (complete and partial)(Up to 5 years)
- Prognostic factors including initial performance status and age(Up to 5 years)
研究者
研究点 (1)
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