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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

February 8, 2006
January 25, 2013
September 1999
March 2006   (final data collection date for 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
  • toxicity
  • activity
Same as current
Complete list of historical versions of study NCT00289445 on ClinicalTrials.gov Archive Site
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Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastrointestinal Neoplasms
  • Neoplasm Metastasis
  • Drug: Mitomycin C
  • Drug: 5-FU
  • Drug: Folinic acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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March 2006
March 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00289445
jth_003
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University Hospital Tuebingen
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Principal Investigator: Carsten Bokemeyer, MD University Hospital Tuebingen (PI until 30Nov2004)
Principal Investigator: Joerg T Hartmann, MD University Hospital Tuebingen
University Hospital Tuebingen
January 2013

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