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Gastrointestinal NeoplasmsPhase 1/2NCT00289445

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

A Phase 1/2 study testing Mitomycin C, 5-FU and Folinic acid in people with Gastrointestinal Neoplasms and Neoplasm Metastasis, run by University Hospital Tuebingen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Mitomycin C, 5-FU and Folinic acid
How many people
Not given
Where
No sites listed yet
Study dates
Sep 1999to Mar 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

About this study

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

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

Being tested
Mitomycin C, 5-FU, Folinic acid
Medical subject headings
Gastrointestinal Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mitomycin CDrug

  • 5-FUDrug

  • Folinic acidDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid

  2. toxicity

  3. activity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2006 (estimated)
  2. Study startSep 1999
  3. Primary completionMar 2006
  4. Study completionMar 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00289445
Sponsor's protocol ID
jth_003
Status last verified
Jan 2013
First submitted
8 Feb 2006
Last updated
28 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Mitomycin C, 5-FU and Folinic acid in people with Gastrointestinal Neoplasms and Neoplasm Metastasis, run by University Hospital Tuebingen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

maximum tolerated dose (MTD) of bolus mitomycin C (MMC) in combination with 24 h-continuous infusion of 5-fluorouracil (FU) plus folinic acid. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00289445.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.

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