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NCT00061893 · ClinicalTrials.gov registry record · Phase 2

Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors

A Phase 2 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 2
Development phase
38
Enrollment target

NCT00061893: Completed Phase 2 study, sponsored by Children's Oncology Group.

NCT00061893 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 38 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

NCT00061893, a Phase 2 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 2
Development phase
38 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of Ewing's sarcoma by stopping blood flow to the tumor. Combining more than one chemotherapy drug with celecoxib may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining low-dose vinblastine and celecoxib with standard regimens of combination chemotherapy in treating patients who have newly-diagnosed metastatic Ewing's sarcoma family of tumors.

Primary Outcome

An incidence of severe toxicity is defined to be the occurrence of grade 3 or higher infection or grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy. If 12 or more patients experience grade 3 or higher infection or five or more patients experience grade 3 or higher sensory neuropathy during cycles 1-2 of protocol therapy, the regimen will be flagged as being associated with an excessive rate of severe toxicity.

Interventions

  • DRUG cyclophosphamide
  • DRUG etoposide
  • DRUG ifosfamide
  • DRUG doxorubicin hydrochloride
  • DRUG celecoxib

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2004-04
Est. Completion 2013-12
Phase Phase 2
Children's Oncology Group

342 total trials

What the finished NCT00061893 record still lists

NCT00061893 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 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 cyclophosphamide is the first listed.

NCT00061893 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00061893 about?

NCT00061893 is a clinical study titled "Vinblastine, Celecoxib, and Combination Chemotherapy in Treating Patients With Newly-Diagnosed Metastatic Ewing's Sarcoma Family of Tumors". RATIONALE: Drugs used in chemotherapy, such as vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. Celecoxib may stop the growth of Ewing's sarcoma by stopping blood flow to the tumor. Combining more than one chemotherapy drug with celecoxib may kill mo...

What is the current status of trial NCT00061893?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2004-04. Estimated completion is 2013-12.

What interventions are being tested in trial NCT00061893?

The interventions under investigation include: cyclophosphamide (DRUG), etoposide (DRUG), ifosfamide (DRUG), doxorubicin hydrochloride (DRUG), celecoxib (DRUG).

Who is sponsoring clinical trial NCT00061893?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00061893's enrollment target sits among peer trials

38 1467th of 2000 higher than 517 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 NCT00061893, the US trial registry maintained by the National Library of Medicine. NCT00061893 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.