Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
Gastrointestinal Neoplasms, Neoplasm Metastasis
About this trial
This is an interventional treatment trial for Gastrointestinal Neoplasms
Eligibility 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