An Open Label Study of Tarceva in Combination With Gemcitabine in Unresectable and/or Metastatic Cancer of the Pancreas : Relationship Between Skin Rash and Survival
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Overall Survival (OS) During the Study
研究概览
简要总结
This single arm study will evaluate the relationship between the skin toxicity of Tarceva in combination with gemcitabine, and survival, in patients with advanced and/or metastatic pancreatic cancer. All patients will receive gemcitabine 100mg/m2 i.v. weekly; Tarceva will be administered 100mg po per day. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •adult patients, >=18 years of age;
- •locally advanced and/or metastatic pancreatic cancer (stage III or IV);
- •Karnofsky performance Status of >=60%.
排除标准
- •local(stage IA to IIB) pancreatic cancer;
- •<=6 months since last adjuvant chemotherapy;
- •previous systemic therapy for metastatic pancreatic cancer;
- •other primary tumor within last 5 years (except for adequately treated cancer in situ of cervix, or basal cell skin cancer);
- •clinically significant cardiovascular disease.
研究组 & 干预措施
Rash, Grade <2
Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
干预措施: Erlotinib (Drug)
Rash, Grade <2
Participants with a rash graded less than (<) 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (v.) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg per (/) square meter (m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
干预措施: Gemcitabine (Drug)
Rash, Grade ≥2
Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
干预措施: Erlotinib (Drug)
Rash, Grade ≥2
Participants with a rash graded greater than or equal to (≥) 2 according to the NCI-CTC v. 3.0 received erlotinib, 100 mg, PO, once per day until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 in 4-week cycles until disease progression, unacceptable toxicity or refusal of patient to continue with the treatment.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Overall Survival (OS) During the Study
时间窗: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
OS was defined as the time, in months, from the date of enrollment to the date of death due to any cause. Participants whose last recorded status was not death were censored. OS was estimated using Kaplan-Meier methodology.
Number of Participants Who Died During the Study
时间窗: Enrollment through Cycle 24 (4-week cycles), up to 24 months.
次要结局
- Number of Participants Who Died at 6 Months(Enrollment through Cycle 6 (4-week cycles), up to 6 months.)
- OS At 6 Months(Enrollment through Cycle 6 (4-week cycles), up to 6 months.)
- Number of Participants Who Died During the Study By Rash Grade(Enrollment through Cycle 24 (4-week cycles), up to 24 months.)
- OS By Rash Grade(Enrollment through Cycle 24 (4-week cycles), up to 24 months.)
- Number of Participants With Disease Progression or Death(Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.)
- PFS(Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months)
- Percentage of Participants With Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST(Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.)
- Percentage of Participants With Disease Control According to RECIST(Enrollment, every 2 treatment cycles (4-week cycles) until disease progression, death, or end of study, for up to 24 months.)