A Phase II Evaluation Of Triapine (NCI-Supplied Agent: NSC #663249, IND #68338) In Combination With Cisplatin (Commercially Available: NSC # 119875) In The Treatment Of Recurrent Or Persistent Platinum-Resistant Ovarian Or Primary Peritoneal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Frequency and duration of objective response assessed using RECIST criteria
研究概览
简要总结
Drugs used in chemotherapy, such as 3-AP and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. This phase II trial is studying how well giving 3-AP together with cisplatin works in treating patients with recurrent or persistent platinum-resistant ovarian epithelial cancer or primary peritoneal cancer
详细描述
PRIMARY OBJECTIVES:
I. Determine the antitumor activity of 3-AP and cisplatin in patients with recurrent or persistent platinum-resistant ovarian epithelial or primary peritoneal cancer.
II. Determine the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the duration of progression-free survival and overall survival in patients treated with this regimen.
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 cancer
- •Recurrent or persistent disease
- •At least 1 unidimensionally measurable target lesion
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Outside a previously irradiated field
- •Received 1 prior platinum-based chemotherapy regimen (e.g., carboplatin, cisplatin, or other organoplatinum compound) for primary disease
- •Initial treatment may have included high-dose, consolidation, or extended therapy after surgical or non-surgical assessment
- •Considered platinum resistant or refractory, according to 1 of the following criteria:
- •Treatment-free interval of less than 6 months after platinum-based therapy
- •Disease progression during platinum-based therapy
- •Ineligible for any higher priority GOG protocol
- •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
- •SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- •Bilirubin ≤ 1.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •No serious cardiac disease
- •No prior myocardial infarction
- •No uncontrolled congestive heart failure
- •No pulmonary disease requiring oxygen
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Neuropathy (sensory and motor) ≤ grade 1
- •No active infections requiring antibiotics
- •No hearing impairment
- •No known G6PD deficiency
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •At least 3 weeks since prior biologic or immunologic agents for malignant tumor
- •One prior non-cytotoxic regimen (e.g., monoclonal antibodies, cytokines, or small-molecule inhibitors of signal transduction) allowed
- •See Disease Characteristics
- •One prior paclitaxel-containing regimen allowed
- •No prior 3-AP
- •No other prior cytotoxic chemotherapy for recurrent or persistent disease, including retreatment with initial chemotherapy regimens
- •Recovered from prior chemotherapy
- •At least 1 week since prior hormonal therapy for malignant tumor
- •Concurrent hormone replacement therapy allowed
- •No prior radiotherapy to more than 25% of marrow-bearing areas
- •Recovered from prior radiotherapy
- •Recovered from prior surgery
- •No prior cancer therapy that contraindicates receiving study therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (triapine and cisplatin)
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: triapine (Drug)
Treatment (triapine and cisplatin)
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: cisplatin (Drug)
Treatment (triapine and cisplatin)
Patients receive 3-AP IV over 2 hours on days 1-4 and cisplatin IV over 1 hour on days 2 and 3. Courses repeat every 21 days 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
Frequency and duration of objective response assessed using RECIST criteria
时间窗: Up to 5 years
Frequency and severity of observed adverse effects assessed using CTCAE version 3.0
时间窗: Up to 5 years
次要结局
- Prognostic variables (e.g., initial performance status, age, and mucinous [or clear cell] histology)(Up to 5 years)
- Duration of progression-free survival(From study entry until disease recurrence, death or date of last contact, assessed up to 5 years)
- Duration of overall survival(From study entry to death or date of last contact, assessed up to 5 years)