Study With Mitomycin c/5-FU/FA in Pretreated Gastrointestinal Cancer Patients With Metastases (>= Second-line Treatment)
This study has been completed.
Sponsor:
University Hospital Tuebingen
Information provided by:
University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT00289445
First received: February 8, 2006
Last updated: January 25, 2013
Last verified: January 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Neoplasms Neoplasm Metastasis |
Drug: Mitomycin C Drug: 5-FU Drug: Folinic acid |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
Resource links provided by NLM:
Further study details as provided by University Hospital Tuebingen:
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
| Study Start Date: | September 1999 |
| Estimated Study Completion Date: | March 2006 |
| Primary Completion Date: | March 2006 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289445
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
| Principal Investigator: | Carsten Bokemeyer, MD | University Hospital Tuebingen (PI until 30Nov2004) |
| Principal Investigator: | Joerg T Hartmann, MD | University Hospital Tuebingen |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00289445 History of Changes |
| Other Study ID Numbers: | jth_003 |
| Study First Received: | February 8, 2006 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Germany: Regierungspräsidium Tübingen (federal level) |
Additional relevant MeSH terms:
|
Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasm Metastasis Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Neoplastic Processes Pathologic Processes Mitomycins Mitomycin Leucovorin Folic Acid Levoleucovorin Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Vitamin B Complex Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Antidotes Protective Agents Hematinics |
ClinicalTrials.gov processed this record on May 16, 2013