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

Primary Purpose

Gastrointestinal Neoplasms, Neoplasm Metastasis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mitomycin C
5-FU
Folinic acid
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    Full Information

    First Posted
    February 8, 2006
    Last Updated
    January 25, 2013
    Sponsor
    University Hospital Tuebingen
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00289445
    Brief Title
    Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1999 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University Hospital Tuebingen

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastrointestinal Neoplasms, Neoplasm Metastasis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Mitomycin C
    Intervention Type
    Drug
    Intervention Name(s)
    5-FU
    Intervention Type
    Drug
    Intervention Name(s)
    Folinic acid
    Primary Outcome Measure Information:
    Title
    maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid
    Title
    toxicity
    Title
    activity

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Carsten Bokemeyer, MD
    Organizational Affiliation
    University Hospital Tuebingen (PI until 30Nov2004)
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Joerg T Hartmann, MD
    Organizational Affiliation
    University Hospital Tuebingen
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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

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