A Phase II Trial of 17-N-Allylamino-17-Demethoxygeldanamycin (17-AAG) in Combination With Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Six Month Survival Rate
研究概览
简要总结
This randomized phase II trial is studying three different schedules of gemcitabine hydrochloride and tanespimycin to see how well they work in treating patients with stage IV pancreatic cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and tanespimycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells
详细描述
PRIMARY OBJECTIVES:
I. To assess the effect of gemcitabine hydrochloride and tanespimycin (17-AAG) on 6-month survival rate in patients with stage IV pancreatic adenocarcinoma.
SECONDARY OBJECTIVES:
I. To determine the overall survival of these patients. II. To determine the time to disease progression (TTP) in these patients. III. To determine the confirmed response rate and duration of response in these patients.
IV. To determine the time to treatment failure in these patients. V. To determine the adverse events in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed pancreatic adenocarcinoma
- •Clinical stage IV disease
- •No known brain metastases
- •ECOG performance status 0-2
- •Life expectancy ≥ 12 weeks
- •Absolute Neutrophil Count (ANC) ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Total bilirubin normal
- •Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases are present)
- •Creatinine normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Ejection fraction > 40% by echocardiogram
- •Patients who received prior anthracyclines must have a normal ejection fraction by echocardiogram
- •Corrected QT interval (QTc) < 500 msec
- •Pulse oximetry > 88% on room air at rest and after gentle exercise (according to Group Medicare Guidelines)
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to tanespimycin (17-AAG) or gemcitabine hydrochloride
- •No known allergy to eggs
- •No concurrent uncontrolled illness including, but not limited to, any of the following:
- •Ongoing or active infection
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Cardiac arrhythmia
- •Psychiatric illness/social situations that would limit compliance with study requirements
- •No active ischemic heart disease within the past 12 months
- •No history of uncontrolled dysrhythmias
- •No congenital long QT syndrome
- •No left bundle branch block
- •No other significant cardiac disease, including any of the following:
- •New York Heart Association class III or IV heart failure
- •Myocardial infarction within the past year
- •Poorly controlled angina
- •Uncontrolled dysrhythmias
- •History of serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)
- •No clinically significant interstitial lung disease
- •No symptomatic pulmonary disease requiring medication, including any of the following:
- •Dyspnea on exertion
- •Paroxysmal nocturnal dyspnea
- •Significant pulmonary disease requiring oxygen*, including chronic obstructive/restrictive pulmonary disease
- •No pulmonary or cardiac symptoms ≥ grade 2
- •No history of cardiac or pulmonary toxicity after receiving anthracyclines (e.g., doxorubicin hydrochloride, daunorubicin hydrochloride, mitoxantrone hydrochloride, bleomycin, or vincristine)
- •No prior chemotherapy for metastatic disease
- •No prior radiotherapy to the chest
- •No prior radiotherapy that potentially included the heart in the field (e.g.,mantle radiotherapy)
- •More than 3 months since prior adjuvant chemotherapy or chemotherapy for locally advanced disease
- •More than 3 weeks since prior radiotherapy
- •No concurrent medications that prolong or may prolong QTc
- •No concurrent antiarrhythmic drugs
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Arm I (combination chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
干预措施: gemcitabine hydrochloride (Drug)
Arm I (combination chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
干预措施: tanespimycin (Drug)
Arm II (combination chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
干预措施: gemcitabine hydrochloride (Drug)
Arm II (combination chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
干预措施: tanespimycin (Drug)
Arm III (combination chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
干预措施: gemcitabine hydrochloride (Drug)
Arm III (combination chemotherapy)
Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
干预措施: tanespimycin (Drug)
结局指标
主要结局
Six Month Survival Rate
时间窗: 6 months
A patient that is alive at 6 months is considered a treatment "success". Estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
次要结局
- Overall Survival Time(Assessed up to 2 years from registration)
- Time to Disease Progression(Time from registration to documentation of disease progression, assessed up to 2 years)
- Confirmed Response Rate(2 consecutive evaluations at least 4 weeks, up to 6 courses of treatment)