临床试验/NCT00093626

NCT00093626已完成2 期

A Phase II Evaluation of BAY 43-9006 (Sorafenib, Nexavar®, NCI-Supplied Agent, NSC #724772) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma

National Cancer Institute (NCI)1 个研究点分布在 1 个国家目标入组 73 人开始时间: 2004年10月最近更新: 2019年7月23日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: National Cancer Institute (NCI)
入组人数: 73
试验地点: 1
主要终点: Progression-free survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. This phase II trial is studying how well sorafenib works in treating patients with persistent or recurrent ovarian epithelial or peritoneal cancer.

详细描述

PRIMARY OBJECTIVES:

I. Determine the efficacy of sorafenib in patients with persistent or recurrent ovarian epithelial or primary peritoneal carcinoma.

II. Determine 6-month progression-free survival of patients treated with this drug.

III. Determine the toxicity of this drug, in terms of frequency and severity of adverse events encountered, in these patients.

SECONDARY OBJECTIVES:

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 ovarian epithelial or primary peritoneal carcinoma
•Persistent or recurrent disease
•Measurable or evaluable disease
•Measurable disease is defined as at least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
•Evaluable disease is defined as at least 1 of the following:
•CA 125 ≥ 2 times upper limit of normal (ULN)
•Ascites and/or pleural effusion attributed to tumor
•Solid and/or cystic abnormalities on radiographic imaging that do not meet RECIST definition for target lesions
•Must have received 1 prior platinum-based chemotherapeutic regimen for primary disease, including carboplatin, cisplatin, or another organoplatinum compound
•Initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment
•Platinum-resistant according to 1 of the following criteria:
•Treatment-free interval of < 12 months after platinum therapy
•Disease progression during platinum-based therapy
•Persistent disease after a platinum-based regimen
•Ineligible for higher priority GOG protocol (e.g., any active phase III GOG protocol for the same patient population)
•No brain metastases
•Performance status - GOG 0-2 (for patients who received 1 prior treatment regimen)
•Performance status - GOG 0-1 (for patients who received 2 prior treatment regimens)
•Absolute neutrophil count ≥ 1,500/mm^3
•Platelet count ≥ 100,000/mm^3
•No known bleeding diathesis
•Bilirubin ≤ 1.5 times ULN
•SGOT ≤ 2.5 times ULN
•Alkaline phosphatase ≤ 2.5 times ULN
•Creatinine ≤ 1.5 times ULN
•No symptomatic congestive heart failure
•No unstable angina pectoris
•No cardiac arrhythmia
•No uncontrolled hypertension
•Able to take oral medication
•No bowel obstruction or persistent vomiting
•No requirement for parenteral feedings
•Not pregnant or nursing
•Negative pregnancy test
•Fertile patients must use effective barrier contraception during and for 3 months after study participation
•No sensory or motor neuropathy > grade 1
•No active or ongoing infection requiring antibiotics
•No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib
•No serious chronic skin conditions (i.e., psoriasis or dermatitis) that would preclude study participation
•No psychiatric illness or social situation that would preclude study compliance
•No other uncontrolled illness
•No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
•At least 3 weeks since prior immunologic agents for the malignancy
•More than 4 weeks since prior mouse antibodies (for patients with evaluable disease only)
•No concurrent prophylactic growth factors (e.g., filgrastim [G-CSF])
•No concurrent prophylactic thrombopoietic agents except in the case of recurrent grade 4 thrombocytopenia
•No other concurrent biological agents for the primary tumor
•See Disease Characteristics
•More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
•No prior non-cytotoxic chemotherapy for persistent or recurrent disease
另有 17 项未显示

排除标准

未提供

研究组 & 干预措施

Treatment (sorafenib tosylate)

Experimental

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: Laboratory Biomarker Analysis (Other)

Treatment (sorafenib tosylate)

Experimental

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: Sorafenib Tosylate (Drug)

结局指标

主要结局

Progression-free survival

时间窗: 6 months

Will be evaluated using proportional hazards modeling and Fisher's exact test.

Frequency and severity of adverse events as assessed by CTCAE v3.0

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 response) defined by RECIST criteria(Up to 5 years)
Prognostic variables (platinum sensitivity, performance status, and cellular histology [clear cell or mucinous type])(Up to 5 years)

研究者

发起方

National Cancer Institute (NCI)

申办方类型

Nih

责任方

Sponsor

研究点 (1)

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