Clinical Trial: Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

Brief Summary: This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.

Detailed Summary:

OBJECTIVES:

I. Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.

II. Determine the cumulative toxicity of this drug in these patients. III. Determine the pharmacokinetic profile of this drug in these patients. IV. Determine time to progression and overall survival of patients treated with this drug.

V. Correlate the extent of oxaliplatin exposure with response in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease type.

Patients receive oxaliplatin IV over 2 hours on day 1. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Response rate [ Time Frame: Up to 3 years ]

Response rate and confidence intervals will be constructed according to the method of Chang and O'Brien.


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: September 7, 2004
Date Started: October 2004
Date Completion:
Last Updated: June 4, 2013
Last Verified: June 2013