Phase 1/2 Study of Gemcitabine/Taxotere/Xeloda (GTX) in Combination With Cisplatin and Irinotecan in Subjects With Metastatic Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Maximum Tolerated Dose (MTD) of Gemcitabine
研究概览
简要总结
This study will be looking at whether gemcitabine, taxotere, and xeloda (GTX) in combination with cisplatin and irinotecan is effective (anti-tumor activity) and safe in patients with metastatic pancreatic cancer.
详细描述
The study is being done in 2 parts. The first part is the dose escalation (Phase I) part of the study where the dose of irinotecan is increased until the highest safe dose of irinotecan is defined that can be given with gemcitabine, taxotere, xeloda, and cisplatin.
After the safe dose of irinotecan in combination with gemcitabine, taxotere, xeloda, and cisplatin is defined, the second part of the study (Phase 2) will use these defined doses to look at how effective these drugs are against advanced pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed untreated metastatic pancreatic adenocarcinoma.
- •Have measurable disease.
- •Male or non-pregnant and non-lactating female of age >18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 . ECOG 0 indicates that the patient is fully active and able to carry on all pre-disease activities without restriction; and, ECOG 1 indicates that the patient is restricted in physically strenuous activity but is ambulatory and able to carry out work of a light or sedentary nature
- •Subjects must have adequate organ and marrow function.
- •Must use acceptable form of birth control prior to study and and for the duration of study.
- •Willing and able to comply with study procedures
排除标准
- •Patient who have had any prior chemotherapy within 5 years of enrollment.
- •Patient who have had radiotherapy for pancreatic cancer.
- •Age ≥ 76 years
- •Patient who is receiving or have received any other investigational agents within 28 days prior to Day 1 of treatment in this study.
- •Patient who has undergone major surgery, other than diagnostic surgery within 28 days prior to Day 1 of treatment in this study.
- •Patient who has known brain metastases.
- •Patient with history of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, taxotere, xeloda, cisplatin, or irinotecan.
- •Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patient who has serious medical risk factors involving any of the major organ systems.
- •Patient who has known history of infection with HIV, hepatitis B, or hepatitis C.
- •Pregnant or breast feeding.
- •Patient is unwilling or unable to comply with study procedures
- •Patient with clinically significant wound
研究组 & 干预措施
Dose level 1 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/twice daily (BID)
- Cisplatin - 15 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Gemcitabine (Drug)
Dose level 1 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/twice daily (BID)
- Cisplatin - 15 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Taxotere (Drug)
Dose level 1 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/twice daily (BID)
- Cisplatin - 15 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Xeloda (Drug)
Dose level 1 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/twice daily (BID)
- Cisplatin - 15 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Cisplatin (Drug)
Dose level 1 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/twice daily (BID)
- Cisplatin - 15 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Irinotecan (Drug)
Dose Level 2 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Gemcitabine (Drug)
Dose Level 2 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Taxotere (Drug)
Dose Level 2 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Xeloda (Drug)
Dose Level 2 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Cisplatin (Drug)
Dose Level 2 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Irinotecan (Drug)
Dose Level 3 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 60 mg/m^2
干预措施: Gemcitabine (Drug)
Dose Level 3 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 60 mg/m^2
干预措施: Taxotere (Drug)
Dose Level 3 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 60 mg/m^2
干预措施: Xeloda (Drug)
Dose Level 3 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 60 mg/m^2
干预措施: Cisplatin (Drug)
Dose Level 3 - Phase 1
- Gemcitabine - 400 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 15 mg/m^2
- Irinotecan - 60 mg/m^2
干预措施: Irinotecan (Drug)
Dose Level 1a - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Gemcitabine (Drug)
Dose Level 1a - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Taxotere (Drug)
Dose Level 1a - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Xeloda (Drug)
Dose Level 1a - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Cisplatin (Drug)
Dose Level 1a - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Irinotecan (Drug)
Dose level 1b - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Gemcitabine (Drug)
Dose level 1b - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Taxotere (Drug)
Dose level 1b - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Xeloda (Drug)
Dose level 1b - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Cisplatin (Drug)
Dose level 1b - Phase 1
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 40 mg/m^2
干预措施: Irinotecan (Drug)
Phase 2
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Gemcitabine (Drug)
Phase 2
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Taxotere (Drug)
Phase 2
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Xeloda (Drug)
Phase 2
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Cisplatin (Drug)
Phase 2
- Gemcitabine - 500 mg/m^2
- Taxotere - 20 mg/m^2
- Xeloda - 500 mg/BID
- Cisplatin - 20 mg/m^2
- Irinotecan - 20 mg/m^2
干预措施: Irinotecan (Drug)
结局指标
主要结局
Maximum Tolerated Dose (MTD) of Gemcitabine
时间窗: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Overall Survival (OS) Rate at 9 Months
时间窗: 9 months
OS will be measured as the percentage of subjects alive at 9 months. (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). Estimation based on the Kaplan-Meier curve. (Phase 2 data only)
Maximum Tolerated Dose (MTD) of Docetaxel
时间窗: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Maximum Tolerated Dose (MTD) of Capecitabine
时间窗: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg for twice daily (BID) use.
Maximum Tolerated Dose (MTD) of Irinotecan
时间窗: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
Maximum Tolerated Dose (MTD) of Cisplatin
时间窗: 28 days
Dose escalation (phase I portion of the trial only) to determine the MTD in mg/m\^2.
次要结局
- Disease Control Rate (DCR) Using RECIST 1.1 Criteria(43 months)
- Response Rate (RR) Using RECIST 1.1 Criteria(43 months)
- Progression-free Survival (PFS) Using RECIST 1.1 Criteria(5 years)
- Overall Survival (OS)(5 years)