NCT00289445已完成1 期
Open, Multi-center Phase I/II Trial With Mitomycin C in Combination With 5-Fluorouracil and Folinic Acid in Pretreated Patients With Metastatic Gastrointestinal Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 主要终点
- maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid
研究概览
简要总结
The aim of this study was to define the maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid, and to assess the toxicity and activity in patients with previously treated colorectal and gastric cancer. Escalating doses of MMC starting from 6 mg m(-2) in 2 mg m(-2)-steps to a maximum of 10 mg m(-2) were applied on days 1 and 22, given to fixed doses of 5-FU (2.600 mg m(-2)) as 24 h infusion and folinic acid 500 mg m(-2) prior to 5-FU weekly for 6 weeks
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Phase 1 (dose escalation)
- •patients with histological proven gastrointestinal neoplasms, without standard therapy option
- •measurable or evaluable disease
- •>= second-line therapy (metastasized stage) Phase 2 (efficacy)
- •patients with proven colorectal neoplasms
- •measurable disease, metastasized
- •previous chemotherapy with 5-FU/FA ("AIO-regimen")
- •age between 18 and 75 years, both male and female
- •life expectancy > 3 months
- •WHO-performance status <= 2
- •adequate bone marrow function: hemoglobin >= 10 mg/dl, neutrophils >= 2.0 * 1000000000/l, thrombocytes >= 150 * 1000000000/l
- •adequate renal and liver function: bilirubin <= 1.25 * ULN(<= 1.5 ULN * by liver metastases), creatinine <= 1.25 * ULN, ASAT and ALAT <= 3 * ULN (<= 5* ULN by liver metastases; AP <= 3* ULN
- •written informed consent prior to inclusion into the study
排除标准
- •pretreated with mitomycin c
- •contraindication concerning 5-FU (e.g. anxiety, myocardial infarction within last 6 months, significant toxicities during previous therapy with 5-FU
- •florid infections
- •ileus or subileus, morbus crohn or colitis, ulcerative
- •actual chronic diarrhea
- •other uncontrolled severe concurrent disease excluding cytotoxic intervention
- •second malignancy except basal cell carcinoma or cervical carcinoma in situ
- •known cns metastases or carcinomatous leptomeningitis
- •pregnancy or lactation period
- •no effective contraception
- •concomitant treatment with another antineoplastic agents
- •participation in another clinical trial within the last 4 weeks
- •patients being unwilling or unable to undergo trial specific procedures
结局指标
主要结局
maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid
toxicity
activity
次要结局
未报告次要终点
研究者
相似试验
终止
1 期
A Safety and Efficacy Study of INC280 Alone, and in Combination With Erlotinib, Compared to Chemotherapy, in Advanced/Metastatic Non-small Cell Lung Cancer Patients With EGFR Mutation and cMET AmplificationNon-Small Cell Lung CancerNCT02468661Novartis Pharmaceuticals23
终止
1 期
E7080 in Combination With Carboplatin + Gemcitabine Versus Carboplatin + Gemcitabine Alone as Second Line Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Cancer by CA125Ovarian CancerNCT01133756Eisai Inc.7
Unknown
2 期
Mitomycin C Therapy for Patients With Primary Sclerosing CholangitisPrimary Sclerosing CholangitisNCT01688024Li, Zhiping, M.D.130
终止
1 期
Safety, Tolerability, Pharmacokinetics, and Efficacy of AZD2811 Nanoparticles as Monotherapy or in Combination in Acute Myeloid Leukemia Participants.Acute Myeloid LeukaemiaNCT03217838AstraZeneca50
尚未招募
3 期
Effect of Mitomycin-C on the Outcomes of Patients Receiving Ahmed Glaucoma Valve Implantation SurgeryGlaucomaNCT06680245St. Joseph's Healthcare Hamilton144