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NCT01320683 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer
A Phase 2 study, sponsored by City of Hope Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT01320683: Clinical Trial Phase 2 study, sponsored by City of Hope Medical Center.
NCT01320683 is a Phase 2 study that was terminated before completion, run by City of Hope Medical Center. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01320683, a Phase 2 study, was terminated before completion, sponsored by City of Hope Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
This phase II trial studies how well giving combination chemotherapy and bevacizumab before surgery and radiolabeled monoclonal antibody therapy works in treating liver metastases in patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and oxaliplatin (FOLFOX), 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 to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A, can find tumor cells and carry tumor-killing substances to them without harming normal cells. Giving chemotherapy and monoclonal antibody before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiolabeled monoclonal antibody therapy after surgery may kill any tumor cells that remain after surgery
Primary Outcome
Estimated using the product-limit method of Kaplan-Meier, and 95% confidence limits calculated for these estimates. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Interventions
- DRUG oxaliplatin
- DRUG fluorouracil
- DRUG leucovorin calcium
- BIOLOGICAL bevacizumab
- RADIATION yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
Why NCT01320683 stopped before completion
NCT01320683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.
NCT01320683 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01320683 about?
NCT01320683 is a clinical study titled "Combination Chemotherapy and Bevacizumab Before Surgery and Radiolabeled Monoclonal Antibody Therapy in Treating Liver Metastases in Patients With Metastatic Colorectal Cancer". This phase II trial studies how well giving combination chemotherapy and bevacizumab before surgery and radiolabeled monoclonal antibody therapy works in treating liver metastases in patients with metastatic colorectal cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, and...
What is the current status of trial NCT01320683?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2011-03. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01320683?
The interventions under investigation include: oxaliplatin (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL), yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A (RADIATION).
Who is sponsoring clinical trial NCT01320683?
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 NCT01320683's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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