A Phase II Study of Gemcitabine and Erlotinib As Adjuvant Therapy In Patients With Resected Pancreatic Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- 2-year Recurrence Free Survival (RFS)
研究概览
简要总结
Study Hypothesis: To estimate time to recurrence in pancreatic cancer patients treated with adjuvant erlotinib and gemcitabine. Combination therapy will be given for 4 months followed by single agent erlotinib for a total of 12 months.
详细描述
PATIENT POPULATION Resected pancreatic cancer patients (R0 resection) within 10 weeks of surgery will be eligible, provided that they meet standard eligibility criteria.
STUDY DESIGN Phase II, open-label trial of erlotinib and gemcitabine. SAFETY PLAN Safety as assessed by CTCAE 3.0 STUDY TREATMENT Erlotinib 150 mg/day x 12 months. (oral) Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months Patients will be monitored with serial CT scans for the first 2 years after completion of therapy.
Clinical Practice: Therapy will be administered as an outpatient. Primary Evaluations: Time to recurrence CONCOMITANT THERAPY AND CLINICAL PRACTICE No other anti-cancer therapy will be allowed while on study.
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
- •Patients with potentially resectable pancreatic cancer (including ampullary cancer), prior to or after surgery will be accrued to this study.
- •Patients who sign consent prior to surgery must have appropriate diagnostic imaging and be evaluated by one of the surgical co-investigators as having resectable disease, and probable pancreatic adenocarcinoma.
- •Patients, who sign consent after surgery, must have adenocarcinoma of the pancreas with negative surgical margins.
- •Adjuvant therapy should start within 10 weeks of surgery
- •Age 18 years or older
- •ECOG performance status of 0 - 1 (see Appendix A)
- •Ability to take oral medications without difficulty
- •Adequate bone marrow function as evidenced by an absolute neutrophil content (ANC) > 1500/mL and platelet count > 100,000/mL
- •Adequate renal function as evidenced by serum creatinine within institutional limits or creatinine clearance > 50 ml/minute if above upper institutional limits (ULN)
- •Adequate hepatic function as evidenced by ALT and total bilirubin within 2 times ULN.
- •Provision of written informed consent.
- •Men and women of childbearing potential must be willing to practice acceptable methods of birth control to prevent pregnancy.
排除标准
- •Positive margins on post operative surgical specimen or evidence of metastatic disease (positive retroperitoneal margin is allowed)
- •Biliary tree cancers are not allowed (Note: Ampullary cancer allowed).
- •Known severe hypersensitivity to erlotinib or any of the excipients of these products
- •Any prior treatment with radiation therapy or chemotherapy or vaccines for pancreatic cancer.
- •Other coexisting malignancies or malignancies diagnosed within the last 3 years, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin or cervical cancer in situ.
- •Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's Wort. Other agents which inhibit CYP3A4 may be used with caution (Appendix B)
- •Treatment with a non-approved or investigational drug prior to treatment.
- •Incomplete healing from previous oncologic or other major surgery.
- •Pregnancy or breast feeding (women of childbearing potential).
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial.
研究组 & 干预措施
Gemcitabine and Erlotinib
Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months
干预措施: Gemcitabine (Drug)
Gemcitabine and Erlotinib
Erlotinib (oral) 150 mg/day x 12 months Gemcitabine 1500 mg/m2 IV over 150 minutes q 2 weeks x 4 months
干预措施: Erlotinib (Drug)
结局指标
主要结局
2-year Recurrence Free Survival (RFS)
时间窗: Up to 60 months
Recurrence Free Survival (RFS)
时间窗: Up to 60 months
The time interval between day 1, cycle 1, of adjuvant treatment to the first date of radiologic recurrence or death.
1-year Recurrence Free Survival (RFS)
时间窗: Up to 60 months
次要结局
- KRAS Mutational Status(Up to 60 months)
- Percentage of Participants With Expression of Epidermal Growth Factor Receptor (EGFR)(Up to 60 months)
- Estimated 1&2 Year Overall Survival (OS)(Up to 60 months)
研究者
Herbert J. Zeh, III MD, FACS
Principal Investigator
University of Pittsburgh