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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 is a Phase 1 study that has completed, run by City of Hope Medical Center. The registered enrollment target is 3 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01205022
The ClinicalTrials.gov registry entry for NCT01205022 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which fluorouracil is the first listed.
NCT01205022 reports 0 study locations.
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.
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