UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With Advanced Ovarian Cancer
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die. UCN-01 may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining UCN-01 with topotecan may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining UCN-01 with topotecan in treating patients who have recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
研究概览
详细说明
OBJECTIVES:
Primary
- Determine the antitumor activity of UCN-01 and topotecan, in terms of complete and partial objective response rates, in patients with recurrent, persistent, or progressive advanced ovarian epithelial, primary peritoneal, or fallopian tube cancer.
Secondary
- Determine the antitumor activity of this regimen, in terms of stable disease rates and duration of response, in these patients.
- Determine the progression-free, median, and overall survival of patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the relationship between clinical and pharmacodynamic effects of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive UCN-01 IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 19-33 patients will be accrued for this study within 5-11 months.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
-
-
Ontario
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Hamilton、Ontario、加拿大、L8V 5C2
- Margaret and Charles Juravinski Cancer Centre
-
London、Ontario、加拿大、N6A 4L6
- Cancer Care Ontario-London Regional Cancer Centre
-
Ottawa、Ontario、加拿大、K1H 8L6
- Ottawa Regional Cancer Centre
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Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer
- Progressive, persistent, or recurrent disease
- Measurable disease outside prior radiotherapy field unless disease progression occurred after radiotherapy
Tumor lesions accessible for biopsy
- Patients with a medical contraindication to tumor biopsy may be allowed at the discretion of the principal investigator
No more than 2 prior chemotherapy regimens
- At least 1 regimen must have contained a platinum agent (i.e., carboplatin or cisplatin)
- No known brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2 OR
- Karnofsky 60-100%
Life expectancy
- More than 12 weeks
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than upper limit of normal (ULN)
- AST/ALT no greater than 2.5 times ULN
Renal
- Creatinine no greater than ULN OR
- Creatinine clearance at least 50 mL/min
Cardiovascular
- No history of coronary artery disease
- No symptomatic cardiac dysfunction
- No cardiac pathology by electrocardiogram* NOTE: *Patients with symptomatic coronary artery disease must undergo an electrocardiogram
Pulmonary
- No symptomatic pulmonary dysfunction
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 8 weeks after study participation
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to UCN-01 or other study agents
No insulin-dependent diabetes mellitus
- Diabetes controlled by diet or oral hypoglycemic agents allowed at the discretion of the investigator
- No other concurrent uncontrolled illness
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 4 weeks since prior biologic therapy and recovered
Chemotherapy
- See Disease Characterisitcs
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- No prior topotecan
- No other prior topoisomerase I inhibitors
Endocrine therapy
- More than 4 weeks since prior hormonal therapy and recovered
Radiotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy and recovered
- No prior radiotherapy to more than 40% of bone marrow
- No prior mediastinal irradiation
Surgery
- More than 4 weeks since prior surgery and recovered
Other
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
合作者和调查者
调查人员
- 首席研究员:Hal W. Hirte, MD, FRCP(C)、Margaret and Charles Juravinski Cancer Centre
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- PMH-PHL-019
- CDR0000339563 (注册表标识符:PDQ (Physician Data Query))
- NCI-6402
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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