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NCT01006369 · ClinicalTrials.gov registry record · Phase 2
Hydroxychloroquine, Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
A Phase 2 study of Colorectal Cancer, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
- 4
- Study locations
NCT01006369: Completed Phase 2 study of Colorectal Cancer, sponsored by Rutgers, The State University of New Jersey.
NCT01006369 is a Phase 2 study of Colorectal Cancer that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 38 participants, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01006369, a Phase 2 study of Colorectal Cancer, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
- 4
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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. Hydroxychloroquine may help chemotherapy and bevacizumab work better and kill more tumor cells. PURPOSE: This phase II trial is studying how well giving hydroxychloroquine together with capecitabine, oxaliplatin, and bevacizumab works in treating patients with metastatic colorectal cancer.
Primary Outcome
Computed Kaplan-Meier survival curve estimates for progression free survival (PFS) and compared to historical controls of median PFS of 240 days. Evaluated response using RECIST criteria every 12 weeks.
Conditions Studied
Interventions
- DRUG hydroxychloroquine
Study Locations (4)
New Jersey
- Cooper Hospital/University Medical Center - Camden
- Cancer Institute of New Jersey at Hamilton - Hamilton
- Rutgers Cancer Institute of New Jersey - New Brunswick
- New Jersey Medical School/The University Hospital Cancer Center - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2009-05 |
| Est. Completion | 2016-04-27 |
| Phase | Phase 2 |
What the finished NCT01006369 record still lists
NCT01006369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 1,545-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Colorectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which hydroxychloroquine is the first listed.
NCT01006369 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT01006369 about?
NCT01006369 is a clinical study titled "Hydroxychloroquine, Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer". RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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 a...
What is the current status of trial NCT01006369?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2009-05. Estimated completion is 2016-04-27.
What conditions does trial NCT01006369 study?
This clinical trial studies the following conditions: Colorectal Cancer.
What interventions are being tested in trial NCT01006369?
The interventions under investigation include: hydroxychloroquine (DRUG).
Who is sponsoring clinical trial NCT01006369?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01006369 being conducted?
This trial has 4 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01006369's enrollment target sits among peer trials
38 309th of 381 higher than 71 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer 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.
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