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NCT00408564 · ClinicalTrials.gov registry record · Phase 2

Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery

A Phase 2 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
39
Enrollment target

NCT00408564: Completed Phase 2 study, sponsored by Medical University of South Carolina.

NCT00408564 is a Phase 2 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 39 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00408564, a Phase 2 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
39 participants
Enrollment target

Study Summary

RATIONALE: Monoclonal antibodies, such as 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. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sometimes when chemotherapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to chemotherapy. Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed. Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. PURPOSE: This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced, nonmetastatic pancreatic cancer that cannot be removed by surgery.

Interventions

  • DRUG oxaliplatin
  • BIOLOGICAL cetuximab
  • DRUG capecitabine
  • PROCEDURE conventional surgery
  • RADIATION radiation therapy

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2006-01
Est. Completion 2013-04
Phase Phase 2

What the finished NCT00408564 record still lists

NCT00408564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (71% lower).

The record links to 0 conditions, and to 5 interventions - of which oxaliplatin is the first listed.

NCT00408564 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00408564 about?

NCT00408564 is a clinical study titled "Cetuximab, Gemcitabine, and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced, Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery". RATIONALE: Monoclonal antibodies, such as 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. Drugs used in chemotherapy, such as gemcitabine, oxaliplatin,...

What is the current status of trial NCT00408564?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 39 participants. The study started on 2006-01. Estimated completion is 2013-04.

What interventions are being tested in trial NCT00408564?

The interventions under investigation include: oxaliplatin (DRUG), cetuximab (BIOLOGICAL), capecitabine (DRUG), conventional surgery (PROCEDURE), radiation therapy (RADIATION).

Who is sponsoring clinical trial NCT00408564?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00408564's enrollment target sits among peer trials

39 1459th of 2000 higher than 534 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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Source: ClinicalTrials.gov NCT00408564, the US trial registry maintained by the National Library of Medicine. NCT00408564 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.