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NCT00257348 · ClinicalTrials.gov registry record · Phase 2
Capecitabine and Docetaxel in Advanced/Recurrent Cervical Cancer
A Phase 2 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT00257348: Completed Phase 2 study, sponsored by University of California, Irvine.
NCT00257348 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 5 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00257348, a Phase 2 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the effectiveness and side effects of the drugs capecitabine and docetaxel in the treatment of cervical cancer. Capecitabine is approved by the FDA for the treatment of breast and colon cancer. Docetaxel is approved in the treatment of breast and lung cancer. The use of capecitabine and docetaxel in this study for the treatment of cervical cancer is considered investigational. Eligible subjects will take the drug capecitabine (Xeloda) by mouth twice a day every 12 hours, for fourteen consecutive days followed by a 7 day rest period. Subjects will also receive the drug docetaxel (Taxotere) intravenously (in the vein) every three weeks.
Primary Outcome
Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Normalization of CA125, if elevated at baseline, is required for ovarian carcinoma studies. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. There can be no unequivocal progression of non-target lesions and no new l
Interventions
- DRUG Docetaxel
- DRUG Capecitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2004-03 |
| Est. Completion | 2007-07 |
| Phase | Phase 2 |
What the finished NCT00257348 record still lists
NCT00257348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT00257348 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00257348 about?
NCT00257348 is a clinical study titled "Capecitabine and Docetaxel in Advanced/Recurrent Cervical Cancer". The purpose of the study is to evaluate the effectiveness and side effects of the drugs capecitabine and docetaxel in the treatment of cervical cancer. Capecitabine is approved by the FDA for the treatment of breast and colon cancer. Docetaxel is approved in the treatment of breast and lung cancer. ...
What is the current status of trial NCT00257348?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2004-03. Estimated completion is 2007-07.
What interventions are being tested in trial NCT00257348?
The interventions under investigation include: Docetaxel (DRUG), Capecitabine (DRUG).
Who is sponsoring clinical trial NCT00257348?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00257348's enrollment target sits among peer trials
5 2000th of 2000 the lowest 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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