Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
Phase 1
Completed
- Conditions
- Gastrointestinal NeoplasmsNeoplasm Metastasis
- Registration Number
- NCT00289445
- Lead Sponsor
- University Hospital Tuebingen
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method