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

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT00289445

Collaborator

(none)

Duration (Months)

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Sep 1, 1999

Actual Primary Completion Date :

Mar 1, 2006

Study Completion Date :

Mar 1, 2006

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

No locations specified.

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