Clinical trial · Interventional
Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Neoplasms | Digestive System Neoplasm | ALIAS | 0.90 |
| Neoplasm Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 5-FU | Drug | Fluorouracil | ALIAS |
| Folinic acid | Drug | — | UNRESOLVED |
| Mitomycin C | Drug | Mitomycin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 proceduresReferences
Publications (0)
Data not yet available