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NCT01183494 · ClinicalTrials.gov registry record · Phase 1
A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients
A Phase 1 study of Metastatic Colorectal Cancer, sponsored by University of Chicago.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 2
- Study locations
NCT01183494: Completed Phase 1 study of Metastatic Colorectal Cancer, sponsored by University of Chicago.
NCT01183494 is a Phase 1 study of Metastatic Colorectal Cancer that has completed, run by University of Chicago. The registered enrollment target is 17 participants, below the 186-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01183494, a Phase 1 study of Metastatic Colorectal Cancer, has completed, sponsored by University of Chicago.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 2
- Study locations
Study Summary
This study is being done to determine the maximum dose of a certain chemotherapy drug (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil (5-FU), leucovorin, and irinotecan; the combination is known as FOLFIRI. At the present time, the Food and Drug Administration (FDA) has approved this drug combination for the treatment of cancers of the colon and rectum. The FDA has also approved the use of a drug called bevacizumab (or Avastin) in combination with FOLFIRI, and this is considered one of the standards of care for all patients with colon and rectal cancer which has spread. The best dose of irinotecan to use in the combination of FOLFIRI and bevacizumab is not known. Earlier studies have shown that higher doses of irinotecan can be used safely as part of the FOLFIRI combination, but it is unclear whether these same doses will be safe when bevacizumab is added to this combination.
Primary Outcome
To define the Maximum Tolerated Dose (MTD), the Dose Limiting Toxicity (DLT), and the recommended dosage of irinotecan administered in first-line therapy with FOLFIRI plus bevacizumab for patients with metastatic CRC and either the UGT1A1\*1/\*1 or UGT1A1\*1/\*28 genotype.
Conditions Studied
Interventions
- DRUG FOLFIRI, Avastin, Irinotecan
Study Locations (2)
Illinois
- The University of Chicago - Chicago
Other
- CRO-National Cancer Institute - Aviano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-12-12 |
| Est. Completion | 2017-06-02 |
| Phase | Phase 1 |
What the finished NCT01183494 record still lists
NCT01183494 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 186-participant average among 45 other Metastatic Colorectal Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Metastatic Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which FOLFIRI, Avastin, Irinotecan is the first listed.
NCT01183494 reports a single indexed study location in Illinois, Other.
Frequently Asked Questions
What is clinical trial NCT01183494 about?
NCT01183494 is a clinical study titled "A Genotype-guided Study of Irinotecan Administered in Combination With 5-fluorouracil/Leucovorin (FOLFIRI) and Bevacizumab in Advanced Colorectal Cancer Patients". This study is being done to determine the maximum dose of a certain chemotherapy drug (irinotecan) that can be tolerated as part of a combination of drugs. There is a combination of chemotherapy drugs typically used to treat cancer of the colon and rectum: 5-Flurouracil (5-FU), leucovorin, and irino...
What is the current status of trial NCT01183494?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2009-12-12. Estimated completion is 2017-06-02.
What conditions does trial NCT01183494 study?
This clinical trial studies the following conditions: Metastatic Colorectal Cancer.
What interventions are being tested in trial NCT01183494?
The interventions under investigation include: FOLFIRI, Avastin, Irinotecan (DRUG).
Who is sponsoring clinical trial NCT01183494?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01183494 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01183494's enrollment target sits among peer trials
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