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NCT00095901 · ClinicalTrials.gov registry record · Phase 2
Capecitabine For Nasopharyngeal Cancer
A Phase 2 study of Head and Neck Cancer, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
- 3
- Study locations
NCT00095901: Completed Phase 2 study of Head and Neck Cancer, sponsored by Dana-Farber Cancer Institute.
NCT00095901 is a Phase 2 study of Head and Neck Cancer that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 3 participants, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00095901, a Phase 2 study of Head and Neck Cancer, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study plans to examine the effects of Capecitabine administered as an oral chemotherapy drug in participants with nasopharyngeal cancer. Capecitabine is an oral prodrug. A "prodrug" is a drug that is converted within the body into its active form that has medical effects. Capecitabine is a prodrug of 5-fluorouracil (5-FU), which is a chemotherapy agent frequently used to treat head and neck cancers. Capecitabine is absorbed through the gastrointestinal tract and is converted to 5-FU. Capecitabine (Xeloda9) has been tested in subjects with colorectal and breast cancers, and shown to be effective in those cancers. Likewise, 5-FU has shown benefit when administered as a continuous infusion for those with nasopharyngeal cancers. Since Capecitabine is a prodrug of 5-FU, it is possible that similar results will be achieved. RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who have locally recurrent or metastatic nasopharyngeal cancer.
Primary Outcome
Tumor response rate based on tumor measurement (according to the nasT criteria). Response Evaluation Criteria in Solid Tumors (RECIST).
Conditions Studied
Interventions
- DRUG Capecitabine
Study Locations (3)
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Dana Farber Cancer Institute - Boston
Illinois
- University of Chicago Cancer Research Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2004-06 |
| Est. Completion | 2007-05 |
| Phase | Phase 2 |
What the finished NCT00095901 record still lists
NCT00095901 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 261-participant average among 250 other Head and Neck Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Head and Neck Cancer appearing as the primary indexed condition, and to 1 intervention - of which Capecitabine is the first listed.
NCT00095901 reports a single indexed study location in Massachusetts, Illinois.
Frequently Asked Questions
What is clinical trial NCT00095901 about?
NCT00095901 is a clinical study titled "Capecitabine For Nasopharyngeal Cancer". This study plans to examine the effects of Capecitabine administered as an oral chemotherapy drug in participants with nasopharyngeal cancer. Capecitabine is an oral prodrug. A "prodrug" is a drug that is converted within the body into its active form that has medical effects. Capecitabine is a pro...
What is the current status of trial NCT00095901?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2004-06. Estimated completion is 2007-05.
What conditions does trial NCT00095901 study?
This clinical trial studies the following conditions: Head and Neck Cancer.
What interventions are being tested in trial NCT00095901?
The interventions under investigation include: Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00095901?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00095901 being conducted?
This trial has 3 study locations across Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Head and Neck 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 NCT00095901's enrollment target sits among peer trials
3 247th of 250 higher than 2 of 250 other Head and Neck Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Head and Neck 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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