NCT00023894已完成2 期
A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 54
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 II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer.
详细描述
OBJECTIVES:
- Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma.
- Determine the nature and degree of toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
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 primary endometrial carcinoma
- •Recurrent or persistent disease
- •Refractory to curative therapy or established treatment
- •Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single agent or combination therapy) for endometrial carcinoma
- •Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •At least 1 target lesion outside previously irradiated field
- •Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol, defined as any active GOG phase III protocol for the same patient population
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •SGOT no greater than 2.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •PT/PTT normal
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No prior thromboembolic events or thrombophlebitis
- •No prior recent myocardial infarction
- •No prior angina
- •No prior cerebrovascular accident
- •No prior transient ischemic attacks
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No grade 2 or greater sensory or motor neuropathy
- •No active infection requiring antibiotics
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma
- •Chemotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered
- •Endocrine therapy:
- •At least 1 week since prior hormonal therapy for endometrial carcinoma
- •Concurrent hormone replacement therapy allowed
- •Radiotherapy:
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered
- •At least 3 weeks since prior surgery for endometrial carcinoma and recovered
- •At least 6 months since prior re-vascularization procedures (e.g., coronary artery bypass graft, carotid endarterectomy or bypass, or angioplasty with or without stents)
- •At least 3 weeks since other prior therapy for endometrial carcinoma
- •At least 6 months since prior thrombolytic procedures
- •No prior cyclin-dependent kinase inhibitors
- •No prior anticancer therapy that would preclude study
- 另有 1 项未显示
排除标准
- 未提供
研究者
研究点 (54)
Loading locations...
相似试验
已完成
2 期
Flavopiridol in Treating Patients With Metastatic Malignant MelanomaMelanoma (Skin)NCT00005971NCIC Clinical Trials Group17
已完成
2 期
Flavopiridol in Treating Patients With Recurrent, Locally Advanced, or Metastatic Soft Tissue SarcomaSarcomaNCT00005974NCIC Clinical Trials Group18
已完成
2 期
Flavopiridol in Treating Patients With Previously Untreated or Relapsed Mantle Cell LymphomaLymphomaNCT00005074NCIC Clinical Trials Group33
已完成
2 期
Flavopiridol in Treating Patients With Unresectable or Metastatic Kidney CancerKidney CancerNCT00016939SWOG Cancer Research Network
已完成
1 期
Flavopiridol Plus Cisplatin or Carboplatin in Treating Patients With Advanced Solid TumorsMelanoma (Skin)Unspecified Adult Solid Tumor, Protocol SpecificBreast CancerProstate CancerNCT00003690Mayo Clinic48