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NCT01722162 · ClinicalTrials.gov registry record · Phase 2
Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT01722162: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT01722162 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01722162, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study Summary
This randomized phase II trial studies how giving a drug called levocetirizine to patients with colorectal cancer affects their tumor response to capecitabine and bevacizumab. Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA synthesis and repair (cell division and survival). Bevacizumab is a monoclonal antibody that blocks the ability of tumors to grow and spread by inhibiting the growth of blood vessels that feed them. Patients with colorectal cancer can develop a resistance to the effects of bevacizumab. Levocetirizine may decrease tumor resistance to bevacizumab. Giving bevacizumab, capecitabine, and levocetirizine dihydrochloride together may be an effective treatment for refractory colorectal cancer.
Primary Outcome
* Time from start of treatment to the time of progression or death, whichever occurs first * Progressive disease (target lesions): at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. * Progressive disease (non-target lesions): appearance of one or more n
Interventions
- DRUG Bevacizumab
- DRUG Capecitabine
- DRUG Levocetirizine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2013-04 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
What the finished NCT01722162 record still lists
NCT01722162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Bevacizumab is the first listed.
NCT01722162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01722162 about?
NCT01722162 is a clinical study titled "Levocetirizine + Capecitabine + Bevacizumab for Patients With Refractory Colorectal Cancer". This randomized phase II trial studies how giving a drug called levocetirizine to patients with colorectal cancer affects their tumor response to capecitabine and bevacizumab. Capecitabine is a chemotherapy drug that blocks tumor growth by disrupting DNA and RNA synthesis and repair (cell division a...
What is the current status of trial NCT01722162?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2013-04. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01722162?
The interventions under investigation include: Bevacizumab (DRUG), Capecitabine (DRUG), Levocetirizine (DRUG).
Who is sponsoring clinical trial NCT01722162?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01722162's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 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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