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NCT00742924 · ClinicalTrials.gov registry record · Phase 1

Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma

A Phase 1 study, sponsored by Children's Oncology Group.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT00742924: Completed Phase 1 study, sponsored by Children's Oncology Group.

NCT00742924 is a Phase 1 study that has completed, run by Children's Oncology Group. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00742924, a Phase 1 study, has completed, sponsored by Children's Oncology Group.

COMPLETED
Registry status
Phase 1
Development phase
24 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects and best dose of zoledronic acid when given together with combination chemotherapy in treating patients with newly diagnosed metastatic osteosarcoma.

Primary Outcome

The occurrence of Limiting Toxicity defined as Any CTC AE version 4 Grade 3 and 4 non-hematologic toxicity thought to be possibly, probably or definitely related to zoledronic acid with the specific exclusion of: * Grade 3 nausea and vomiting controlled with adequate antiemetic prophylaxis. * Grade 3 transaminase (AST/ALT) that occurs during the evaluation period but resolves to ≤ Grade 2, before the planned dose of therapy after definitive surgery. * Grade 3 fever or infection. * Grade 3 or 4

Interventions

  • DRUG cisplatin
  • DRUG etoposide
  • DRUG ifosfamide
  • DRUG dexrazoxane hydrochloride
  • DRUG doxorubicin hydrochloride

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2008-08
Phase Phase 1
Children's Oncology Group

342 total trials

What the finished NCT00742924 record still lists

NCT00742924 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).

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

NCT00742924 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00742924 about?

NCT00742924 is a clinical study titled "Zoledronic Acid and Combination Chemotherapy in Treating Patients With Newly Diagnosed Metastatic Osteosarcoma". RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This clinical trial is studying the side effects an...

What is the current status of trial NCT00742924?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2008-08.

What interventions are being tested in trial NCT00742924?

The interventions under investigation include: cisplatin (DRUG), etoposide (DRUG), ifosfamide (DRUG), dexrazoxane hydrochloride (DRUG), doxorubicin hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00742924?

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 NCT00742924's enrollment target sits among peer trials

24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00742924, the US trial registry maintained by the National Library of Medicine. NCT00742924 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.