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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00289445

Enrollment

Unknown

Registered

2006-02-09

Start date

1999-09-30

Completion date

2006-03-31

Last updated

2013-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Neoplasms, Neoplasm Metastasis

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

Interventions

DRUGMitomycin C

DRUG5-FU

DRUGFolinic acid

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid	—
toxicity	—
activity	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026