A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, With Pegfilgrastim for the Treatment of Patients With Metastatic Transitional Cell Carcinoma and Renal Insufficiency
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Objective Response Rate
研究概览
简要总结
This phase II trial is studying how well giving gemcitabine, paclitaxel, and doxorubicin together with pegfilgrastim works in treating patients with metastatic or unresectable bladder cancer or urinary tract cancer and kidney dysfunction. Drugs used in chemotherapy, such as gemcitabine, paclitaxel, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony stimulating factors, such as pegfilgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with pegfilgrastim may kill more tumor cells. Chemotherapy drugs may have different effects in patients who have changes in their kidney function.
详细描述
PRIMARY OBJECTIVES:
I. Assess the efficacy of gemcitabine hydrochloride, paclitaxel, doxorubicin hydrochloride, and pegfilgrastim, in terms of response rate, in patients with metastatic or unresectable transitional cell carcinoma of the bladder or urinary tract and renal insufficiency.
SECONDARY OBJECTIVES:
I. Assess the safety and tolerability of this regimen in these patients. II. Determine the median time to progression in patients treated with this regimen.
III. Determine the median survival duration in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed transitional cell carcinoma (TCC) of the bladder, urethra, or upper urinary tract
- •Mixed TCC and variant histologies (i.e., small cell, squamous cell, adenocarcinoma, or sarcoma) allowed if present in < 50% of the biopsy specimen
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of this study, in keeping with the policies of the institution.
- •Measurable disease: may include radiographic detection of metastases in lymph nodes (>= 1.5 cm) or liver or lung (>= 1.0 cm) OR pelvic mass palpable on examination under anesthesia
- •Creatinine clearance < 60 mL/min; no renal insufficiency that requires hemodialysis; no renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy)
- •Zubrod performance status 0-2
- •Platelet count > 100,000/mm^3
- •Absolute granulocyte count > 1,500/mm^3
- •Bilirubin =< 2.0 mg/dL
- •Aminotransferases (AST and ALT) =< 2 times upper limit of normal
- •Left ventricular ejection fraction (LVEF) > 40% OR normal electrocardiogram (EKG or ECG) and no history of cardiac disease
- •All patients must be evaluated in the Department of Genitourinary Medical Oncology at M. D. Anderson Cancer Center or participating CCOP center prior to signing informed consent.
- •No prior systemic chemotherapy including, adjuvant or neoadjuvant therapy
- •Prior intravesicular chemotherapy allowed
排除标准
- •No brain metastases
- •Not pregnant or nursing
- •No severe or uncontrolled infection
- •No New York Heart Association class III-IV congestive heart failure, unstable angina, or history of myocardial infarction within the past 6 months
- •No peripheral neuropathy >= grade 2
- •No persistently uncontrolled diabetes mellitus
- •No chronic liver disease
- •No HIV positivity
- •No other malignancy except nonmelanoma skin cancer unless disease-free for the past 3 years
- •No overt psychosis, mental disability, or other condition that would preclude giving informed consent
- •No known sickle cell disease
- •No uncontrolled severe hypertension
- •Renal insufficiency that requires hemodialysis or renal insufficiency that is reversible in patients with tumor confined to the primary site (i.e., that is potentially resectable with neoadjuvant chemotherapy).
研究组 & 干预措施
Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 min; Doxorubicin 40 mg/m^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
干预措施: Gemcitabine hydrochloride (Drug)
Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 min; Doxorubicin 40 mg/m^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
干预措施: Paclitaxel (Drug)
Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 min; Doxorubicin 40 mg/m^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
干预措施: Doxorubicin hydrochloride (Drug)
Gemcitabine, Paclitaxel and Doxorubicin
Paclitaxel 135 mg/m^2 intravenous (IV) over 1 hour; Gemcitabine 900 mg/m^2 IV over 90 min; Doxorubicin 40 mg/m^2 IV over 20 min; treatment may repeat every 2 weeks for up to nine courses. Injection of Pegfilgrastim on day 1.
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: Up to 12 weeks, or following completion 6 cycles of chemotherapy, respectively; the best response achieved within 6 cycles of starting chemotherapy used to calculate response rate.
The percentage of participants with either Complete Response (CR) or Partial Response (PR) in their disease burden based upon the rules of the Response Evaluation Criteria in Solid Tumors (RECIST). A participant with of all of the lesions disappearing is a CR. A participant with at least a 30 percent decrease in the measured lesions is a PR.
次要结局
- Overall Survival (OS) of Participants With a Continuous Complete Response, Partial Response and Stable Disease(Registration Date of each participant for up to three years or death whichever came first)
- Safety and Efficacy of Same-day Pegfilgrastim(Up to 3 years)