Clinical trial NCT00289445: Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Gastrointestinal Neoplasms
Neoplasm Metastasis
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2006-02-09
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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


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

Primary outcomes:
measure: maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid
measure: toxicity
measure: activity
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Tuebingen (PI until 30Nov2004)
name: Carsten Bokemeyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Tuebingen
name: Joerg T Hartmann, MD
role: PRINCIPAL_INVESTIGATOR
References: