NCT00397787已完成2 期
A Phase II Study of Sunitinib Malate (SU11248, NSC #736511, IND #74,019) in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front-Line Gemcitabine-Based Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Response (CR/PR/stable disease) as measured by RECIST criteria
研究概览
简要总结
This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVES:
I. To determine the response rate to sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.
SECONDARY OBJECTIVES:
I. To determine the duration of response, progression-free survival and overall survival of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.
II. To determine the safety of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma.
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
- 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
- •Histologic or cytologic documentation of pancreatic adenocarcinoma with evidence of disease progression following first-line therapy is required
- •No brain metastases
- •Patients with measurable disease
- •Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded as >= 20 mm with conventional techniques or as>= 10 mm with spiral computed tomography (CT) scan; of particular note, the primary pancreatic tumor does not constitute measurable disease; therefore, patients with locally advanced pancreatic cancer as the sole site of disease are not eligible
- •Patients must have received one of the following prior therapies containing gemcitabine:
- •One and only one prior therapy for metastatic disease with gemcitabine, or a gemcitabine-containing cytotoxic combination, or
- •One prior chemoradiation therapy containing gemcitabine for inoperable locally advanced pancreatic cancer, as long as the patient has subsequently progressed and has measurable disease outside a radiation port, or
- •One prior adjuvant chemotherapy regimen or chemoradiation therapy containing gemcitabine if the patient subsequently progressed within 3 months of completion of adjuvant therapy; patients who have received chemoradiation in the adjuvant setting must have measurable disease outside the radiation port
- •No prior therapy with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.)
- •At least 4 weeks must have elapsed prior to initiation of treatment since the completion of chemotherapy and/or radiation therapy
- •At least 4 weeks must have elapsed prior to registration since any major surgery
- •Prior erlotinib is permitted; the last dose must have been administered 14 or more days prior to initiation of treatment; all erlotinib related side effects must have resolved to < grade 1 prior to registration
- •No significant cardiac disease including:
- •QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant EKG abnormalities
- •History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to registration
- •History of class III or IV heart failure within 12 months prior to registration as defined by the NYHA functional classification system
- •In addition, patients with history of hypertension must be well controlled (< 140/90) on a regimen of anti-hypertensive therapy
- •Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
- •The use of inhibitors and inducers of CYP3A4 is not permitted:
- •The following inhibitors of CYP3A4 is prohibited within 7 days before beginning and during treatment with sunitinib:
- •Azole antifungals (ketoconazole, itraconazole)
- •Diltiazem
- •Clarithromycin
- •Erythromycin
- •Verapamil
- •Delavirdine
- •HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
- •The following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib:
- •Rifabutin
- •Carbamazepine
- •Phenobarbital
- •Phenytoin
- •St. John's wort
- •Efavirenz
- •Tipranavir
- •Other inhibitors or inducers of CYP3A4 may be used if necessary, but their use is discouraged
- •The use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, flecainide) is not permitted during the study
- •ECOG performance status 0-2
- •No history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration
- •No history of pulmonary embolism within the past 6 months
- •Patients who require use of therapeutic doses of coumadin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's PT INR is < 1.5
- •No serious or non-healing wound, ulcer, or bone fracture
- •No history (within 6 months) of significant bleeding events (e.g., upper or lower GI bleeding, hemoptysis, or hematuria), abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
- •No evidence of duodenal invasion by the tumor on CT scan
- •No "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
- •Non-pregnant and not breast feeding; pregnant women are excluded from this study because sunitinib is an antiangiogenic agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib, breastfeeding should be discontinued if the mother is treated with sunitinib malate
- •ANC >= 1,500/μl
- •Platelet count >= 100,000/μl
- •Bilirubin < 1.5 mg/dL
- •PT and PTT =< 1.5 X ULN
- 另有 2 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (sunitinib malate)
Experimental
Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Response (CR/PR/stable disease) as measured by RECIST criteria
时间窗: At 6 weeks post-initiation of protocol treatment
次要结局
- Response duration(Up to 2 years)
- Progression-free survival (PFS)(Up to 2 years)
- Overall survival (OS)(Up to 2 years)
- Number and percentage of patients reporting common and serious adverse events (AEs), the AEs related to sunitinib, reason for study discontinuation, clinically significant laboratory abnormalities, and AEs with worst NCI CTCAE grade(Up to 2 years)
研究者
研究点 (2)
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