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

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Tuebingen
• Treatments: Folic Acid; Leucovorin; Levoleucovorin; Mitomycin; Mitomycins

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