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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Gastrointestinal Neoplasms, Neoplasm Metastasis

Intervention / Treatment
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* Drug: Mitomycin C
* Drug: 5-FU
* Drug: Folinic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mitomycin C|nan|
|Drug: 5-FU|nan|
|Drug: Folinic acid|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  |