A Pilot Study of Pioglitazone as Second Line Therapy for Patients With Previously Treated Metastatic Adenocarcinoma of the Pancreas With Disease Progression After Gemcitabine Based Chemotherapy
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Changes in weight as measured at baseline, every 4 weeks during therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years
研究概览
简要总结
RATIONALE: Pioglitazone may slow the growth of tumor cells and may be an effective treatment for pancreatic cancer.
PURPOSE: This phase I trial is studying how well pioglitazone works as second-line therapy in treating patients with metastatic pancreatic cancer that progressed after treatment with gemcitabine.
详细描述
OBJECTIVES:
Primary
- To describe changes in markers of insulin resistance, including serum adiponectin levels, standard glucose tolerance testing, and fasting serum glucose and insulin levels, in patients with previously treated metastatic adenocarcinoma of the pancreas treated with pioglitazone hydrochloride as second-line therapy.
- To describe changes in weight in these patients.
- To describe changes in ECOG performance status in these patients.
- To describe changes in symptoms and quality of life of these patients using the validated FACT-Hep scale version 4 questionnaire.
Secondary
- To determine the tumor response as measured by RECIST criteria in these patients.
- To determine the time to disease progression in these patients.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed adenocarcinoma of the pancreas
- •Metastatic disease
- •Previously treated disease
- •Disease progression after first-line gemcitabine hydrochloride-based chemotherapy
- •Radiologically measurable disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL
- •Serum creatinine < 1.5 times upper limit of normal (ULN) OR creatinine clearance > 45 mL/min
- •Total bilirubin ≤ 1.5 times ULN
- •AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- •No NYHA class III-IV congestive heart failure
- •No unstable angina
- •No second malignancy except for localized nonmelanoma skin cancer
- •No psychiatric or addictive disorders that would preclude giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •Prior systemic therapy with fluorouracil, capecitabine, oxaliplatin, or erlotinib hydrochloride allowed
- •More than 12 months since prior and no other concurrent thiazolinediones
- •More than 6 months since prior treatment with immunosuppressive or immunomodulatory agents
- •No other concurrent anticancer therapy
排除标准
- 未提供
结局指标
主要结局
Changes in weight as measured at baseline, every 4 weeks during therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years
Fasting serum glucose and insulin levels as measured at baseline, every 4 weeks during therapy, and then at the completion of therapy
Changes in ECOG performance status as measured at baseline, weekly during the first course of therapy, every 4 weeks during the rest of therapy, at the completion of therapy, and then monthly for 6 months and every 3 months for 2 years
Changes in symptoms and quality of life as measured by the validated FACT-Hep scale version 4 questionnaire at baseline, every 4 weeks during therapy, and then at the completion of therapy
Insulin resistance markers as measured by standard glucose tolerance testing and serum adiponectin levels at baseline, every 4 weeks during therapy, and then at the completion of therapy
次要结局
- Objective response (confirmed complete or partial response) as measured by RECIST criteria
- Time to disease progression