NCT00079872已完成2 期
A Randomized Phase 2 Trial of ALIMTA Plus a Comparator Versus Leucovorin Modulated Fluorouracil Plus a Comparator in First Line Treatment of Locally Advanced or Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 7
- 主要终点
- The primary objective is to compare the antitumor activity of pemetrexed plus a comparator with that of leucovorin modulated 5 FU plus a comparator as measured by tumor response rate for patients with locally advanced or metastatic colorectal cancer
研究概览
简要总结
In this study, patients will receive either pemetrexed plus irinotecan or 5-fluorouracil (5-FU), leucovorin, and irinotecan.
The purposes of this study are to determine:
- How pemetrexed plus irinotecan compares with 5-FU, leucovorin, and irinotecan in terms of efficacy.
- The safety of pemetrexed plus irinotecan and any side effects that might be associated with it as compared with 5-FU, leucovorin, and irinotecan.
- Whether pemetrexed can help patients with colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •The patient must have:
- •Histologic or cytologic diagnosis of adenocarcinoma of the colon or rectum.
- •Performance status of 0 to 2 on the ECOG Performance Status Scale.
- •Standard postoperative adjuvant radiation therapy for rectal cancer is allowed.
- •Locally advanced or metastatic disease.
- •Must be 18 years of age.
排除标准
- •The patient must not have:
- •Received prior chemotherapy for advanced disease. Prior adjuvant therapy, including 5-FU, is allowed if it has been more than 12 months since the last treatment.
- •Received prior treatment with irinotecan in the adjuvant setting.
- •Are unable to take vitamin B12 or folic acid.
- •Are unable to interrupt aspirin, other nonsteroidal anti-inflammatory drugs, or COX-2 inhibitors for a 5-day period.
- •Have a second primary malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence.
结局指标
主要结局
The primary objective is to compare the antitumor activity of pemetrexed plus a comparator with that of leucovorin modulated 5 FU plus a comparator as measured by tumor response rate for patients with locally advanced or metastatic colorectal cancer
次要结局
- The secondary objectives of the study are as follows:
- to assess the following time to event efficacy endpoints for patients in both treatment arms:
- overall survival
- progression free survival
- duration of response
- to characterize the quantitative and qualitative toxicities of both treatment arms in this patient population
研究者
研究点 (7)
Loading locations...
相似试验
已完成
1 期
A Trial of ALIMTA (Pemetrexed) Plus Irinotecan in Patients Who Have Been Previously Treated For Metastatic Colorectal Cancer.Colorectal CancerNCT00034502Eli Lilly and Company
已完成
2 期
Pemetrexed Plus Gemcitabine in Metastatic Breast Cancer Patients After Receiving Taxane TherapyBreast NeoplasmsBreast CancerNCT00063570Eli Lilly and Company73
Unknown
2 期
Pemetrexed + Paclitaxel in Patients With Recurrent/Advanced Thyroid CancerThyroid CancerNCT00786552University Hospital Schleswig-Holstein47
已完成
2 期
Study of Pemetrexed and Bevacizumab in Patients With Head and Neck CancerCancerNCT00222729University of Pittsburgh42
已完成
1 期
Trial of Pemetrexed and Carboplatin in Patients With Recurrent Ovarian or Primary Peritoneal CancerPrimary Peritoneal CancerOvarian CancerNCT00489359Eli Lilly and Company86