COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00289445
Recruitment Status : Completed
First Posted : February 9, 2006
Last Update Posted : January 28, 2013
Information provided by:
University Hospital Tuebingen

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

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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
Study Start Date : September 1999
Actual Primary Completion Date : March 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Folic Acid

Primary Outcome Measures :
  1. maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid
  2. toxicity
  3. activity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00289445

Sponsors and Collaborators
University Hospital Tuebingen
Layout table for investigator information
Principal Investigator: Carsten Bokemeyer, MD University Hospital Tuebingen (PI until 30Nov2004)
Principal Investigator: Joerg T Hartmann, MD University Hospital Tuebingen
Layout table for additonal information Identifier: NCT00289445    
Other Study ID Numbers: jth_003
First Posted: February 9, 2006    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Folic Acid
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Growth Substances
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors