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Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)

NCT00289445 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2013-01-28

No results posted yet for this study

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

Conditions

  • Gastrointestinal Neoplasms
  • Neoplasm Metastasis

Interventions

DRUG

Mitomycin C

DRUG

5-FU

DRUG

Folinic acid

Sponsors & Collaborators

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Carsten Bokemeyer, MD · University Hospital Tuebingen (PI until 30Nov2004)

  • Joerg T Hartmann, MD · University Hospital Tuebingen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-30
Primary Completion
2006-03-31
Completion
2006-03-31

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00289445 on ClinicalTrials.gov