drugset / Trial / NCT00289445
Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
Non-randomizedSingle-groupOpen-labelTreatment
Summary
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
Timeline
- Start
- 1999-09
- Primary completion
- 2006-03
- Completion
- 2006-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mitomycin C | Other / unclassified | 6 mg/m2 | — |
| Subject | Mitomycin C | Other / unclassified | 8 mg/m2 | — |
| Subject | Mitomycin C | Other / unclassified | 10 mg/m2 | — |
| Background | Leucovorin | Small molecule | 500 mg/m2 | — |
| Background | fluorouracil | Small molecule | 2600 mg/m2 | — |