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

University Hospital Tuebingen

Status and phase

Completed

Phase 2

Phase 1

Conditions

Neoplasm Metastasis

Gastrointestinal Neoplasms

Treatments

Drug: 5-FU

Drug: Mitomycin C

Drug: Folinic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT00289445

jth_003

Details and patient eligibility

About

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

Sex

All

Ages

18 to 75 years old

Volunteers

No 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