NCT00425360已完成3 期
A Prospective, Phase III, Controlled, Multicentre, Randomised Clinical Trial Comparing Combination Gemcitabine and Capecitabine Therapy With Concurrent and Sequential Chemoimmunotherapy Using a Telomerase Vaccine in Locally Advanced and Metastatic Pancreatic Cancer [TELOVAC]
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,110
- 试验地点
- 45
- 主要终点
- Survival at 1 year
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving more than one drug (combination chemotherapy) together with vaccine therapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective with or without vaccine therapy in treating pancreatic cancer.
PURPOSE: This randomized phase III trial is studying gemcitabine, capecitabine, and vaccine therapy to see how well they work compared with gemcitabine and capecitabine alone in treating patients with locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy of telomerase peptide vaccine GV1001 when administered concurrently or sequentially with gemcitabine hydrochloride and capecitabine, in terms of survival, in patients with locally advanced or metastatic pancreatic cancer.
Secondary
- Determine the safety of this regimen in these patients.
- Assess the immunogenicity of this regimen in these patients.
- Determine the time to progression in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the clinical benefit response in patients treated with this regimen.
- Determine the objective response rate in patients treated with this regimen.
- Determine the toxicity of this regimen in these patients.
- Determine the survival and response by delayed-type hypersensitivity in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed pancreatic ductal adenocarcinoma or undifferentiated carcinoma of the pancreas
- •Locally advanced or metastatic disease precluding curative surgical resection
- •Unidimensionally measurable disease by CT scan
- •No intracerebral metastases or meningeal carcinomatosis
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •Life expectancy > 3 months
- •WBC > 3,000/mm³
- •Absolute neutrophil count > 1,500/mm³
- •Platelet count > 100,000/mm³
- •Bilirubin < 2.0 mg/dL
- •Creatinine clearance > 50 mL/min
- •No medical or psychiatric condition that would preclude giving informed consent
- •No clinically significant serious disease or organ system disease not currently controlled on present therapy
- •No uncontrolled angina pectoris
- •Not pregnant or nursing
- •Fertile patients must use a condom and ≥ 1 other form of contraception during and for 1 year after completion of study treatment
- •No other malignancies or invasive cancers within the past 5 years except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix
- •No known malabsorption syndrome
- •No known hypersensitivity to any of the investigational agents
- •No dihydropyrimidine dehydrogenase deficiency
- •PRIOR CONCURRENT THERAPY:
- •No prior chemotherapy
- •No radiotherapy within the past 4 weeks
- •No concurrent medications that could affect immunocompetence (e.g., chronic treatment with long-term steroids or other immunosuppressants for unrelated condition)
- •Concurrent short-term steroids for palliation of cancer-related symptoms allowed
- •No other concurrent investigational drugs or cytotoxic agents
- •No other concurrent immunotherapy (e.g., immunosuppressants or chronic use of systemic corticosteroids) or chemotherapy for another tumor in patients receiving telomerase peptide vaccine GV1001
- •Concurrent low-dose corticosteroids may be allowed
排除标准
- 未提供
结局指标
主要结局
Survival at 1 year
次要结局
- Time to progression
- Quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life (QLQ) C30 questionnaire and the European Study group for Pancreatic Cancer-QLQ questionnaire
- Clinical benefit response
- Objective response rate as assessed by RECIST criteria
- Toxicity as assessed by NCI CTCAE version 3
- Survival and response as assessed by delayed-type hypersensitivity
研究者
研究点 (45)
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