Status:
COMPLETED
Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Gastrointestinal Neoplasms
Neoplasm Metastasis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00289445
Start Date
September 1 1999
End Date
March 1 2006
Last Update
January 28 2013
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