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NCT01205022 · ClinicalTrials.gov registry record · Phase 1
Radiolabeled Monoclonal Antibody Therapy, Combination Chemotherapy, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
A Phase 1 study, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT01205022: Completed Phase 1 study, sponsored by City of Hope Medical Center.
NCT01205022 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01205022, a Phase 1 study, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and either kill them or carry tumor-killing substances to them without harming normal cells. Giving radioactive substances together with antibodies may be effective treatment for some advanced cancers. Drugs used in chemotherapy, such as irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI), work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving radiolabeled monoclonal antibodies together with combination chemotherapy and bevacizumab may be an effective treatment for colorectal cancer. PURPOSE: This phase I trial is studying the side effects, best way to give, and best dose of yttrium Y 90 DOTA anti-CEA (Carcinoembryonic antigen) monoclonal antibody M5A when given together with combination chemotherapy and bevacizumab in treating patients with metastatic colorectal cancer.
Interventions
- DRUG fluorouracil
- DRUG leucovorin calcium
- BIOLOGICAL bevacizumab
- DRUG irinotecan hydrochloride
- RADIATION yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2011-04 |
| Est. Completion | 2014-01 |
| Phase | Phase 1 |
What the finished NCT01205022 record still lists
NCT01205022 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which fluorouracil is the first listed.
NCT01205022 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01205022 about?
NCT01205022 is a clinical study titled "Radiolabeled Monoclonal Antibody Therapy, Combination Chemotherapy, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer". RATIONALE: Radiolabeled monoclonal antibodies can find tumor cells and either kill them or carry tumor-killing substances to them without harming normal cells. Giving radioactive substances together with antibodies may be effective treatment for some advanced cancers. Drugs used in chemotherapy, suc...
What is the current status of trial NCT01205022?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2011-04. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01205022?
The interventions under investigation include: fluorouracil (DRUG), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL), irinotecan hydrochloride (DRUG), yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A (RADIATION).
Who is sponsoring clinical trial NCT01205022?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01205022's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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