A Phase II Trial of Bevacizumab (NSC# 704865) and OSI-774 (NSC# 718781) In Recurrent Ovarian Cancer, Fallopian Tube Carcinoma or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Response rate of patients treated with the combination of bevacizumab and OSI-774
研究概览
简要总结
This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer. Monoclonal antibodies, such as bevacizumab, 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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving bevacizumab together with erlotinib may kill more tumor cells.
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with recurrent or metastatic ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer treated with bevacizumab and erlotinib.
SECONDARY OBJECTIVES:
I. Determine the toxic effects of this regimen in these patients. II. Determine the median progression-free survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
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 or cytologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer
- •Recurrent or metastatic disease
- •Measurable disease, defined as ≥ 1 unidimensionally measurable indicator lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- •Must have received a platinum-containing chemotherapy regimen for primary disease
- •Re-treatment with a platinum-based regimen required for patients who achieved a clinical complete response (CR) to primary therapy and then had a treatment-free interval > 12 months (i.e., platinum-sensitive) unless the patient developed a hypersensitivity to platinum
- •Patients with a treatment-free interval < 12 months do not require prior chemotherapy for recurrent disease
- •No evidence of CNS disease, including primary brain tumors or brain metastasis
- •Performance status - ECOG 0-2
- •More than 3 months
- •WBC ≥ 3,000/mm^3
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •No history of bleeding diathesis
- •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if due to liver metastasis)
- •Bilirubin normal
- •INR ≤ 1.5 (3 if receiving warfarin)
- •No history of esophageal varices
- •Creatinine ≤ 1.5 mg/dL
- •Creatinine clearance ≥ 60 mL/min
- •Urine protein < 1+
- •Urine protein < 1,000 mg on 24-hour urine collection
- •Urine protein:creatinine ratio < 1.0
- •No arterial thromboembolic event within the past 6 months, including any of the following:
- •Transient ischemic attack
- •Cerebrovascular accident
- •Unstable angina pectoris
- •Myocardial infarction
- •No clinically significant peripheral artery disease
- •No uncontrolled hypertension
- •No New York Heart Association grade II-IV congestive heart failure
- •No serious cardiac arrhythmia requiring medication
- •No peripheral vascular disease ≥ grade 2
- •Not pregnant
- •No nursing during and for ≥ 3 months after study participation
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 3 months after study participation
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to study drugs (e.g., Chinese hamster ovary cell products or recombinant humanized antibodies)
- •No serious or non-healing wound, ulcer, or bone fracture
- •No active infection requiring parenteral antibiotics
- •No other active malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No gastrointestinal tract disease resulting in an inability to take oral medication
- •No significant traumatic injury within the past 28 days
- •No known HIV positivity
- •No prior bevacizumab
- •See Disease Characteristics
- •No more than 2 prior cytotoxic chemotherapy regimens for recurrent or refractory disease (i.e., failed to achieve a clinical CR after primary therapy)
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •More than 4 weeks since prior radiotherapy
- •No prior radiotherapy to any indicator lesion unless disease has progressed since completion of radiotherapy
- •More than 4 weeks since prior major surgical procedure or open biopsy
- 另有 13 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (bevacizumab, erlotinib hydrochloride)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.
干预措施: bevacizumab (Biological)
Treatment (bevacizumab, erlotinib hydrochloride)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone in the absence of disease progression or unacceptable toxicity.
干预措施: erlotinib hydrochloride (Drug)
Treatment (bevacizumab, erlotinib hydrochloride)
Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oral erlotinib once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients experiencing unacceptable toxicity due to 1 of the study drugs may continue treatment with the remaining study drug alone 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
Response rate of patients treated with the combination of bevacizumab and OSI-774
时间窗: Up to 5 years
次要结局
- Progression-free survival(Time from treatment commencement to disease progression or death, whichever comes first, assessed up to 5 years)
- Median progression-free survival(From start of treatment to time of progression, assessed up to 5 years)
- Overall survival(Up to 5 years)