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

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289445
• Other study ID #: jth_003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 8, 2006
• Last updated: January 25, 2013
• Start date: September 1999
• Est. completion date: March 2006

Study information

• Verified date: January 2013
• Source: University Hospital Tuebingen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Tübingen (federal level)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• Mitomycin C

• 5-FU

• Folinic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Outcome

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