A Phase II Evaluation of Vorinostat, (SAHA, NCI-Supplied Agent [NSC #701852]) in the Treatment of Persistent or Recurrent Epithelial Ovarian or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This phase II trial is studying how well vorinostat works in treating patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. Determine the 6-month progression-free survival rate in patients with recurrent or persistent ovarian epithelial or primary peritoneal cavity cancer treated with vorinostat.
II. Determine the toxicity of this drug, in terms of the frequency and severity of adverse reactions in these patients.
SECONDARY OBJECTIVES:
I. Determine the clinical response rate (partial response and complete response) in patients treated with this drug.
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 cavity cancer
- •Recurrent or persistent disease
- •Disease progression during OR persistent disease after completion of 1 prior platinum-based chemotherapy regimen (containing carboplatin, cisplatin, or other organoplatinum compound) for primary disease
- •Initial treatment may have included high-dose, consolidation, noncytotoxic agents, or extended therapy administered after surgical or non-surgical assessment
- •Treatment-free interval after completion of platinum-based chemotherapy must have been < 12 months
- •Measurable disease, defined as ≥ 1 unidimensionally measurable target* lesion ≥ 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR ≥ 10 mm by spiral CT scan
- •Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG protocol for the same patient population)
- •No known brain metastases
- •Performance status - GOG 0-1
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin ≤ 1.5 times upper limit of normal (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
- •Able to take oral medication
- •No bowel obstruction
- •No persistent vomiting
- •No parenteral feeding
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
- •No neuropathy (sensory and motor) > grade 1
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No active infection requiring antibiotics
- •No psychiatric illness or social situation that would preclude study compliance
- •No history of allergic reaction attributed to compounds of similar chemical or biological composition to vorinostat
- •No other uncontrolled illness
- •At least 4 weeks since prior immunotherapy for the malignancy
- •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) for the malignancy and recovered
- •No more than 2 prior cytotoxic chemotherapy regimens for recurrent or persistent disease
- •No prior non-cytotoxic chemotherapy for recurrent or persistent disease, unless therapy was part of the primary treatment regimen
- •No prior vorinostat
- •At least 1 week since prior hormonal therapy for the malignancy
- •Concurrent hormone replacement therapy allowed
- •At least 4 weeks since prior radiotherapy for the malignancy and recovered
- •No prior radiotherapy to > 25% of bone marrow
- •At least 4 weeks since prior surgery for the malignancy and recovered
- •At least 4 weeks since other prior therapy for the malignancy
- •At least 30 days since prior and no concurrent valproic acid
- •Concurrent oral anticoagulants (i.e., warfarin) allowed provided there is increased vigilance with respect to monitoring PT/INR for the first 2 courses of study therapy or if there are any signs of bleeding
- •No prior anticancer therapy that would preclude study participation
- •No concurrent combination anti-retroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
排除标准
- 未提供
研究组 & 干预措施
Treatment (vorinostat)
Patients receive oral vorinostat twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: vorinostat (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: At 6 months
Time at risk will be assessed from the date of registration onto the study and include all eligible patients who receive any study treatment. An analysis of any potential treatment effect on PFS may be conducted against the historical controls provided in GOG 126 and GOG 146 using a proportional hazards model that includes histological cell type, performance status, and platinum sensitivity.
Toxicity as assessed by CTCAE v 3.0
时间窗: Up to 5 years after completion of study treatment
次要结局
- Clinical response (partial and complete response) rate as according to RECIST s(Up to 5 years)
- Duration of PFS(From study entry until disease progression, death or date of last contact., assessed up to 5 years)
- Duration of survival(From entry into the study to death or the date of last contact, assessed up to 5 years)