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

This study is ongoing, but not recruiting participants.

First Received: February 8, 2006 Last Updated: April 19, 2007 History of Changes

Sponsored by:	University Hospital Tuebingen
Information provided by:	University Hospital Tuebingen
ClinicalTrials.gov Identifier:	NCT00289445

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 I Phase II

MedlinePlus related topics: Cancer

Drug Information available for: Mitomycin Fluorouracil Leucovorin Folic acid Citrovorum factor Mitomycins Leucovorin Calcium Folinic acid calcium salt pentahydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

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

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

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

Study ID Numbers:	jth_003
Study First Received:	February 8, 2006
Last Updated:	April 19, 2007
ClinicalTrials.gov Identifier:	NCT00289445 History of Changes
Health Authority:	Germany: Regierungspräsidium Tübingen (federal level)

Study placed in the following topic categories:

Vitamin B Complex
Digestive System Neoplasms
Hematinics
Gastrointestinal Diseases
Leucovorin
Trace Elements
Mitomycins
Folic Acid
Anti-Bacterial Agents

Digestive System Diseases
Fluorouracil
Vitamins
Mitomycin
Neoplasm Metastasis
Gastrointestinal Neoplasms
Micronutrients
Alkylating Agents

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Antineoplastic Agents
Hematologic Agents
Physiological Effects of Drugs
Leucovorin
Antibiotics, Antineoplastic
Mitomycins
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Vitamins
Mitomycin

Neoplasm Metastasis
Micronutrients
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Digestive System Neoplasms
Vitamin B Complex
Hematinics
Growth Substances
Enzyme Inhibitors
Pharmacologic Actions
Folic Acid
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009