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Oxaliplatin in Treating Children With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00005844
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 23, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

June 2, 2000
January 27, 2003
October 23, 2012
April 2000
September 2007   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00005844 on ClinicalTrials.gov Archive Site
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Oxaliplatin in Treating Children With Advanced Solid Tumors
A Phase I Study of Oxaliplatin in Children With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of oxaliplatin in treating children who have advanced solid tumors.


  • Determine the maximum tolerated dose of oxaliplatin in children with advanced solid tumors.
  • Determine the toxic effects of this drug in these patients.
  • Determine the safety of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Assess the relationship between pharmacokinetic parameters and toxicity of this regimen and response in these patients.
  • Determine the anti-tumor effects of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oxaliplatin IV over 2 hours on day 1 (every 3 weeks for up to 6 courses) OR on days 1, 14, and 28 (every 6 weeks for up to 3 courses). Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of oxaliplatin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Once the MTD for dose levels 1-4 is determined, an additional cohort of 3-6 patients is accrued and treated with oxaliplatin as above every 2 weeks (for up to 9 doses).

PROJECTED ACCRUAL: Approximately 6-20 patients will be accrued for this study within 1-3.3 years.

Phase 1
Primary Purpose: Treatment
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: oxaliplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
September 2007
September 2007   (Final data collection date for primary outcome measure)


  • Histologically confirmed metastatic or unresectable solid tumors that are not amenable to standard treatment

    • Histological confirmation not required for brain stem tumors
  • No known brain metastases
  • No leukemia



  • 21 and under

Performance status:

  • ECOG 0-2 OR
  • Lansky 50-100%

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,000/mm^3 (except with marrow involvement)
  • Hemoglobin at least 8 g/dL
  • Platelet count at least 100,000/mm^3


  • Bilirubin 0.2-1.4 mg/dL
  • AST/ALT no greater than 3 times upper limit of normal


  • Creatinine normal for age OR
  • Creatinine clearance at least 50 mL/min
  • Electrolytes, calcium, and phosphorus normal


  • No symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • HIV negative
  • No active graft-vs-host disease (GVHD)
  • No allergy to platinum compounds or antiemetics
  • No uncontrolled concurrent illness or infection
  • No evidence of neuropathy
  • Blood sugar normal


Biologic therapy:

  • At least 1 week since prior hematopoietic growth factors
  • At least 3 months since prior stem cell transplantation and recovered


  • At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea)

Endocrine therapy:

  • Not specified


  • At least 6 weeks since prior extensive radiotherapy to significant marrow-containing compartment
  • At least 6 months since prior craniospinal radiotherapy; total abdominal, pelvic, or extensive lung radiotherapy; or mantle and Y-port radiotherapy
  • At least 6 months since prior total body irradiation


  • Not specified


  • No concurrent therapy for GVHD
  • No other concurrent anticancer investigational or commercial agents
  • No other concurrent anticancer therapy
Sexes Eligible for Study: All
up to 21 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
SJCRH-OXAL1 ( Other Identifier: St. Jude Children's Research Hospital )
NCI-T99-0059 ( Other Identifier: National Cancer Institute )
Not Provided
Not Provided
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Study Chair: Sheri L. Spunt, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP