NCT00017017已完成1 期
A Phase I/II Trial fo Intravenous CT-2103 in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I/II trial to study the effectiveness of CT-2103 in treating patients who have recurrent ovarian epithelial or fallopian tube cancer or primary peritoneal cancer.
详细描述
OBJECTIVES:
- Determine the response rate and time to treatment failure in patients with recurrent ovarian epithelial, fallopian tube, or primary peritoneal carcinoma treated with CT-2103.
- Determine the tolerability and safety of the previously established dose and schedule of CT-2103 in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive CT-2103 IV over 10 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
If no more than 1 of the first 6 patients experience dose-limiting toxicity, then the remaining patients receive a higher dose of CT-2103.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma
- •Recurrent disease following prior initial therapy with platinum-based regimen
- •No more than 2 prior cytotoxic chemotherapy regimens for recurrent disease
- •No more than 1 prior non-platinum, non-taxane regimen
- •At least 1 site of radiographically measurable disease AND/OR
- •CA-125 levels at least 50% above upper limits of normal for a minimum of 2 samples
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status
- •Karnofsky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin less than 1.5 times upper limit of normal (ULN)
- •SGOT less than 1.5 times ULN
- •Alkaline phosphatase less than 1.5 times ULN
- •Creatinine no greater than 1.5 mg/dL
- •No unresolved, pre-existing grade 2 or greater neurotoxicity from prior treatment with neurotoxic drugs
- •No active uncontrolled infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 weeks after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •At least 4 weeks since prior immunotherapy and recovered
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •Endocrine therapy
- •At least 4 weeks since prior endocrine therapy and recovered
- •Radiotherapy
- •At least 4 weeks since prior radiotherapy (except for palliative reasons) and recovered
- •Not specified
- •At least 4 weeks since other prior investigational drugs and recovered
排除标准
- 未提供
研究者
研究点 (1)
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