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

This study has been completed.
Information provided by:
University Hospital Tuebingen Identifier:
First received: February 8, 2006
Last updated: January 25, 2013
Last verified: January 2013
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

Condition Intervention Phase
Gastrointestinal Neoplasms Neoplasm Metastasis Drug: Mitomycin C Drug: 5-FU Drug: Folinic acid Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: 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

Resource links provided by NLM:

Further study details as provided by University Hospital Tuebingen:

Primary Outcome Measures:
  • 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

Study Start Date: September 1999
Estimated Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00289445

Sponsors and Collaborators
University Hospital Tuebingen
Principal Investigator: Carsten Bokemeyer, MD University Hospital Tuebingen (PI until 30Nov2004)
Principal Investigator: Joerg T Hartmann, MD University Hospital Tuebingen
  More Information Identifier: NCT00289445     History of Changes
Other Study ID Numbers: jth_003
Study First Received: February 8, 2006
Last Updated: January 25, 2013

Additional relevant MeSH terms:
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Folic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances
Hematinics processed this record on August 23, 2017