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NCT00040391 · ClinicalTrials.gov registry record · Phase 2
A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer
A Phase 2 study, sponsored by Celgene Corporation.
- Terminated
- Registry status
- Phase 2
- Development phase
NCT00040391 is a Phase 2 study that was terminated before completion, run by Celgene Corporation.
The verdict
NCT00040391, a Phase 2 study, was terminated before completion, sponsored by Celgene Corporation.
- TERMINATED
- Registry status
- Phase 2
- Development phase
Study Summary
The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (also known as 5-FU), and leucovorin (also known as LV). This is known as the triple therapy. One of the major side effects of CPT-11/5-FU/LV chemotherapy treatment is diarrhea. The purpose of this research study is to see whether adding this investigational drug to the standard treatment for advanced colorectal cancer can reduce the amount of diarrhea a patient experiences. This study will also determine if adding the investigational drug to triple therapy has a positive effect on tumors.
Interventions
- DRUG Leucovorin
- DRUG Irinotecan
- DRUG 5-fluorouracil
- DRUG Investigational drug
Trial Details
| Field | Value |
|---|---|
| Start Date | 2002-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00040391
The ClinicalTrials.gov registry entry for NCT00040391 describes a study currently listed as terminated, categorized as Phase 2. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Celgene Corporation, which has 40 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Leucovorin is the first listed.
NCT00040391 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00040391 about?
NCT00040391 is a clinical study titled "A Trial of an Investigational Drug for the Prevention of Diarrhea Associated With Irinotecan/5FU/Leucovorin Chemotherapy in Previously Untreated Metastatic Colorectal Cancer". The study will combine a new investigational drug with standard anti-cancer drugs for the treatment of advanced colorectal cancer. The standard and approved treatment for colorectal cancer is to undergo chemotherapy with a combination of irinotecan (also known as CPT-11, Camptosar), 5-fluorouracil (...
What is the current status of trial NCT00040391?
This trial is currently terminated. It is a Phase 2 study. The study started on 2002-06.
What interventions are being tested in trial NCT00040391?
The interventions under investigation include: Leucovorin (DRUG), Irinotecan (DRUG), 5-fluorouracil (DRUG), Investigational drug (DRUG).
Who is sponsoring clinical trial NCT00040391?
This trial is sponsored by Celgene Corporation, which has 40 total clinical trials registered on ClinicalTrials.gov.
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