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NCT00509665 · ClinicalTrials.gov registry record · Phase 2
Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer
A Phase 2 study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
NCT00509665: Completed Phase 2 study, sponsored by Medical University of South Carolina.
NCT00509665 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 18 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00509665, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with doxorubicin works in treating patients with recurrent or progressive head and neck cancer.
Primary Outcome
Per Response Evaluation Criteria in Solid Tumors (RECIST) for target lesions assessed by CT or MRI: Complete Response (CR) is the disappearance of all target lesions (TL) and non-target lesions (NTL); Partial Response (PR) is defined by either a CR of TL and stable disease (SD) in NTL or PR of TL and non-progressive disease (PD) in NTL. Response rate is the sum of CR + PR as defined above.
Interventions
- DRUG doxorubicin hydrochloride
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2005-06 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
What the finished NCT00509665 record still lists
NCT00509665 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which doxorubicin hydrochloride is the first listed.
NCT00509665 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00509665 about?
NCT00509665 is a clinical study titled "Gemcitabine and Doxorubicin in Treating Patients With Recurrent or Progressive Head and Neck Cancer". RATIONALE: Drugs used in chemotherapy, such as gemcitabine and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II...
What is the current status of trial NCT00509665?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2005-06. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00509665?
The interventions under investigation include: doxorubicin hydrochloride (DRUG), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00509665?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00509665's enrollment target sits among peer trials
18 1898th of 2000 higher than 98 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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