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Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX
NCT00381862 · View on ClinicalTrials.gov ↗
Study Summary
RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy. PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused by chemotherapy in patients receiving chemotherapy for metastatic colorectal cancer.
Conditions Studied
Interventions
- DRUG dexamethasone
- DRUG fluorouracil
- DRUG leucovorin calcium
- DRUG irinotecan hydrochloride
- DRUG aprepitant
Study Locations (6)
Georgia
- St. Josephs/Cander Hospital — Savannah
Hawaii
- Kaiser Permanente — Hilo
Illinois
- Ingalls Memorial Hospital — Harvey
Missouri
- Kansas City Cancer Center — Kansas City
Oregon
- OHSU Knight Cancer Institute — Portland
Texas
- Texas A & M university / Scott and White Clinic — Temple
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2006-06 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00381862
The ClinicalTrials.gov registry entry for NCT00381862 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is OHSU Knight Cancer Institute, which has 242 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 5 interventions — of which dexamethasone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00381862 reports 6 study locations spanning 6 distinct geographic areas — top geographies include Georgia, Hawaii, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00381862 about?
NCT00381862 is a clinical study titled "Phase II Trial of Aprepitant & Palonosetron for CINV Prevention w FOLFOX". RATIONALE: Aprepitant, palonosetron, and dexamethasone may help lessen or prevent nausea and vomiting in patients receiving chemotherapy. PURPOSE: This phase II trial is studying how well giving aprepitant together with palonosetron and dexamethasone works in preventing nausea and vomiting caused b...
What is the current status of trial NCT00381862?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2006-06. Estimated completion is 2008-07.
What conditions does trial NCT00381862 study?
This clinical trial studies the following conditions: Colorectal Cancer, Nausea and Vomiting. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00381862?
The interventions under investigation include: dexamethasone (DRUG), fluorouracil (DRUG), leucovorin calcium (DRUG), irinotecan hydrochloride (DRUG), aprepitant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00381862?
This trial is sponsored by OHSU Knight Cancer Institute, which has 242 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00381862 being conducted?
This trial has 6 study locations across Georgia, Hawaii, Illinois, Missouri, Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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