NCT00025194已完成1 期
A Phase I And Randomized Phase 2 Trial Of Epothilone B Analogue BMS 247550 (NSC # 710428) Administered Every 21 Days With Or Without Oral Estramustine Phosphate In Patients With Androgen Independent Prostate Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 7
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as ixabepilone and estramustine, use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether BMS-247550 is more effective with or without estramustine in treating prostate cancer.
PURPOSE: This randomized phase I/II trial is studying the best dose of ixabepilone when given together with estramustine and to see how well giving ixabepilone together with estramustine works compared to ixabepilone alone in treating patients with progressive prostate cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of ixabepilone combined with estramustine in patients with progressive androgen-independent adenocarcinoma of the prostate. (Phase I)
- Compare the safety and efficacy of ixabepilone with or without estramustine in this patient population. (Phase II)
- Correlate the clinical outcomes with reverse transcriptase-polymerase chain reaction-based assay for prostate-specific antigen mRNA in patients treated with these regimens.
OUTLINE: This is a dose-escalation study of ixabepilone (phase I) followed by a randomized, multicenter study (phase II).
- Phase I: Patients receive ixabepilone IV over 3 hours on day 2 and oral estramustine 3 times daily on days 1-5. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ixabepilone until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the prostate
- •Must have disease progression meeting 1 of the following criteria:
- •Rising prostate-specific antigen (PSA) on at least 3 consecutive measurements taken more than 1 week apart
- •Measurable disease, defined as new or progressive soft tissue masses on CT scan or MRI
- •New metastatic lesions by radionuclide bone scan
- •The most recent PSA must be at least 4 ng/mL if no measurable disease is present
- •Ineligible if sole manifestation of progressive disease is an increase in disease-related symptoms
- •Serum testosterone no greater than 50 ng/mL
- •One of the following therapies for maintenance of castrate status required:
- •Must continue on gonadotropin-releasing hormone analogs (e.g., leuprolide or goserelin) to maintain castrate levels of serum testosterone
- •Developed disease progression after discontinuation of the antiandrogen that was part of the first-line hormonal therapy
- •Prior surgical orchiectomy
- •Developed disease progression after discontinuation of megestrol
- •No known brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 70-100%
- •Life expectancy:
- •Not specified
- •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
- •No history of bleeding disorder that would preclude anticoagulation with warfarin
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper limit of normal (ULN)
- •PT/PTT normal (unless anticoagulated for other reasons [e.g., atrial fibrillation])
- •Creatinine no greater than 1.5 times ULN
- •Cardiovascular:
- •No significant cardiovascular disease
- •No symptomatic congestive heart failure
- •No New York Heart Association class III or IV heart disease
- •No active unstable angina pectoris
- •No cardiac arrhythmia
- •No myocardial infarction within the past 6 months
- •No history of hemorrhagic or thrombotic cerebrovascular accident or deep venous thrombosis within the past 6 months
- •No pulmonary embolism within the past 6 months
- •Fertile patients must use effective contraception
- •No history of allergic reactions to compounds of similar chemical or biological composition to the epothilones
- •No history of recent gastrointestinal bleeding that would preclude anticoagulation with warfarin
- •No other concurrent active malignancy except nonmelanomatous skin cancer
- •Disease not considered currently active if completely treated with less than a 30% risk for relapse
- •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:
- •No concurrent routine filgrastim (G-CSF) or sargramostim (GM-CSF) except for neutropenic fever
- 另有 19 项未显示
排除标准
- 未提供
研究者
研究点 (7)
Loading locations...
相似试验
撤回
2 期
Carboplatin, Ixabepilone, and Cetuximab in Patients With Stage III or Stage IV Non-Small Cell Lung Cancer Previously Untreated With ChemotherapyLung CancerNCT00998101UNC Lineberger Comprehensive Cancer Center
终止
1 期
Ixabepilone and Hydroxychloroquine in Treating Patients With Metastatic Breast CancerBreast CancerNCT00765765University of Medicine and Dentistry of New Jersey6
已完成
2 期
Ixabepilone in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal CancerPeritoneal Cavity CancerOvarian CancerNCT00030706Montefiore Medical Center
已完成
1 期
Ixabepilone and Vorinostat in Treating Patients With Metastatic Breast CancerRecurrent Breast CancerStage IV Breast CancerMale Breast CancerNCT01084057City of Hope Medical Center56
已完成
2 期
Mitoxantrone, Etoposide, and Vinorelbine As Second-Line Therapy in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone TherapyProstate CancerNCT00627354Groupe D'Etude des Tumeurs Uro-Genitales90