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
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