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NCT00184002 · ClinicalTrials.gov registry record · Phase 2
Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas
A Phase 2 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
NCT00184002: Completed Phase 2 study, sponsored by University of Southern California.
NCT00184002 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00184002, a Phase 2 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
Study Summary
The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.
Primary Outcome
Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response. If after 4 cycles of therapy complete response or partial response has been documented, therapy will continue. If stable or progressive disease has been documented, the patient will be withdrawn from the study. Response to the study treatment will be determined according to the criteria proposed in the "Report of an International Workshop to Sta
Interventions
- DRUG Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2003-01-10 |
| Est. Completion | 2013-05-07 |
| Phase | Phase 2 |
What the finished NCT00184002 record still lists
NCT00184002 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 1 intervention - of which Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone is the first listed.
NCT00184002 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00184002 about?
NCT00184002 is a clinical study titled "Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas". The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R...
What is the current status of trial NCT00184002?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2003-01-10. Estimated completion is 2013-05-07.
What interventions are being tested in trial NCT00184002?
The interventions under investigation include: Doxorubicin, Rituxan, Cyclophosphamide, Vincristine and Prednisone (DRUG).
Who is sponsoring clinical trial NCT00184002?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00184002's enrollment target sits among peer trials
68 967th of 2000 higher than 1,027 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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