Spots Global Cancer Trial Database for Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
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Trial Identification
Brief Title: Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
Official Title: 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
Study ID: NCT00289445
Study Description
Brief 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
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Carsten Bokemeyer, MD
Affiliation: University Hospital Tuebingen (PI until 30Nov2004)
Role: PRINCIPAL_INVESTIGATOR
Name: Joerg T Hartmann, MD
Affiliation: University Hospital Tuebingen
Role: PRINCIPAL_INVESTIGATOR
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