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NCT00305877 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 137
- Enrollment target
NCT00305877: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00305877 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00305877, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 137 participants
- Enrollment target
Study Summary
This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. Monoclonal antibodies, such as bevacizumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab or cetuximab together with gemcitabine, capecitabine, and radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating pancreatic cancer.
Primary Outcome
Specific toxicities to be monitored pursuant to the primary endpoint include: 1. Any grade 5 toxicities 2. Grade 4 dyspnea, neutropenic fever, allergic reaction, rash, wound dehiscence, wound infection, hypertension 3. Grade 3 or higher arterial thromboembolic phenomena, bleeding, phlebitis/deep vein thrombosis (DVT)/pulmonary embolism (PE), hemorrhage, ileus, bowel perforation, diarrhea, and mucositis 4. ECOG performance status decline by 2 or greater for \>24 hours 5. Weight loss \>10%
Interventions
- BIOLOGICAL cetuximab
- DRUG capecitabine
- RADIATION radiation therapy
- BIOLOGICAL bevacizumab
- DRUG gemcitabine hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2006-02 |
| Est. Completion | 2012-02 |
| Phase | Phase 2 |
What the finished NCT00305877 record still lists
NCT00305877 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which cetuximab is the first listed.
NCT00305877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00305877 about?
NCT00305877 is a clinical study titled "Bevacizumab or Cetuximab And Gemcitabine Hydrochloride, Capecitabine, and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery". This randomized phase II trial is studying bevacizumab to see how well it works compared to cetuximab when given together with gemcitabine, capecitabine, and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery. Monoclonal antibodies, such as beva...
What is the current status of trial NCT00305877?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2006-02. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00305877?
The interventions under investigation include: cetuximab (BIOLOGICAL), capecitabine (DRUG), radiation therapy (RADIATION), bevacizumab (BIOLOGICAL), gemcitabine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00305877?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00305877's enrollment target sits among peer trials
137 527th of 2000 higher than 1,474 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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