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

This study has been completed.
Sponsor:
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00289445
First received: February 8, 2006
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289445

Sponsors and Collaborators
University Hospital Tuebingen
Investigators
Principal Investigator: Carsten Bokemeyer, MD University Hospital Tuebingen (PI until 30Nov2004)
Principal Investigator: Joerg T Hartmann, MD University Hospital Tuebingen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00289445     History of Changes
Other Study ID Numbers: jth_003
Study First Received: February 8, 2006
Last Updated: January 25, 2013
Health Authority: Germany: Regierungspräsidium Tübingen (federal level)

Additional relevant MeSH terms:
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Neoplastic Processes
Pathologic Processes
Mitomycins
Mitomycin
Leucovorin
Folic Acid
Levoleucovorin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antidotes
Protective Agents
Hematinics

ClinicalTrials.gov processed this record on August 20, 2014