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NCT00305643 · ClinicalTrials.gov registry record · Phase 3
Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer
A Phase 3 study, sponsored by M.D. Anderson Cancer Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 11
- Enrollment target
NCT00305643: Clinical Trial Phase 3 study, sponsored by M.D. Anderson Cancer Center.
NCT00305643 is a Phase 3 study that was terminated before completion, run by M.D. Anderson Cancer Center. The registered enrollment target is 11 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00305643, a Phase 3 study, was terminated before completion, sponsored by M.D. Anderson Cancer Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 11 participants
- Enrollment target
Study Summary
RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may kill more tumor cells. Celecoxib may prevent or lessen hand-foot syndrome caused by capecitabine. PURPOSE: This randomized phase III trial is studying how well celecoxib works in preventing hand/foot syndrome caused by capecitabine in patients with metastatic breast or colorectal cancer.
Primary Outcome
The primary classification of palmar planter erythrodysethesia according to National Cancer Institute Common Toxicity Criteria (CTC) 3.0 criteria used to determine the incidences of \> grade 1 hand and foot syndrome (HFS) by 16 weeks from the commencement of therapy.
Interventions
- DRUG Placebo
- DRUG Capecitabine
- DRUG Celecoxib
- PROCEDURE Radiation Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2006-02 |
| Est. Completion | 2008-10 |
| Phase | Phase 3 |
Why NCT00305643 stopped before completion
NCT00305643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00305643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00305643 about?
NCT00305643 is a clinical study titled "Celecoxib in Preventing Hand/Foot Syndrome Caused By Capecitabine With Metastatic Breast or Colorectal Cancer". RATIONALE: Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with capecitabine may...
What is the current status of trial NCT00305643?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 11 participants. The study started on 2006-02. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00305643?
The interventions under investigation include: Placebo (DRUG), Capecitabine (DRUG), Celecoxib (DRUG), Radiation Therapy (PROCEDURE).
Who is sponsoring clinical trial NCT00305643?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00305643's enrollment target sits among peer trials
11 1989th of 2000 higher than 12 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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