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

This study has been completed.

Sponsor:

Information provided by:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT00289445

First received: February 8, 2006

Last updated: January 25, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2006

Last Updated Date

January 25, 2013

Start Date ^ICMJE

September 1999

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00289445 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Gastrointestinal Neoplasms
Neoplasm Metastasis

Intervention ^ICMJE

Drug: Mitomycin C
Drug: 5-FU
Drug: Folinic acid

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Not Provided

Completion Date

March 2006

Primary Completion Date

March 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00289445

Other Study ID Numbers ^ICMJE

jth_003

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University Hospital Tuebingen

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Carsten Bokemeyer, MD	University Hospital Tuebingen (PI until 30Nov2004)
Principal Investigator:	Joerg T Hartmann, MD	University Hospital Tuebingen

Information Provided By

University Hospital Tuebingen

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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