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Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
This study has been completed.
Study NCT00091182   Information provided by National Cancer Institute (NCI)
First Received: September 7, 2004   Last Updated: July 23, 2008   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

September 7, 2004
July 23, 2008
October 2004
  • Response rate [ Designated as safety issue: No ]
  • Cumulative toxicity [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Correlation of the extent of drug exposure with response [ Designated as safety issue: No ]
  • Response rate
  • Cumulative toxicity
  • Pharmacokinetics
  • Time to progression
  • Overall survival
  • Correlation of the extent of drug exposure with response
Complete list of historical versions of study NCT00091182 on ClinicalTrials.gov Archive Site
 
 
 
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: 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.

OBJECTIVES:

  • Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin.
  • Determine the cumulative toxicity of this drug in these patients.
  • Determine the pharmacokinetic profile of this drug in these patients.
  • Determine time to progression and overall survival of patients treated with this drug.
  • 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.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Phase II
Interventional
Treatment, Open Label
  • Adrenocortical Carcinoma
  • Brain and Central Nervous System Tumors
  • Childhood Germ Cell Tumor
  • Colorectal Cancer
  • Extragonadal Germ Cell Tumor
  • Head and Neck Cancer
  • Kidney Cancer
  • Liver Cancer
  • Neuroblastoma
  • Ovarian Cancer
  • Sarcoma
Drug: oxaliplatin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
180
 
February 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed* solid tumor, including any of the following:

    • Ewing's sarcoma/peripheral primitive neuroectodermal tumor (PNET)
    • Osteosarcoma
    • Rhabdomyosarcoma
    • Neuroblastoma
    • High-grade astrocytoma
    • Low-grade astrocytoma
    • Glioblastoma multiforme
    • Ependymoma
    • Hepatoblastoma
    • Germ cell tumors of any site
    • Rare tumors of interest, including any of the following:

      • Soft tissue sarcoma
      • Hepatocellular carcinoma
      • Childhood/adolescent colorectal carcinoma
      • Childhood/adolescent renal cell carcinoma
      • Childhood/adolescent adrenocortical carcinoma
      • Childhood/adolescent nasopharyngeal carcinoma NOTE: *Histologic confirmation not required for brain stem tumors and visual pathway gliomas
  • Recurrent disease OR refractory to conventional therapy
  • Measurable disease by clinical exam, CT scan, MRI, or positron emission tomography

PATIENT CHARACTERISTICS:

Age

  • 21 and under at original diagnosis

Performance status

  • Karnofsky 50-100% (for patients over age 10) OR
  • Lansky 50-100% (for patients age 10 and under)

Life expectancy

  • At least 8 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3*
  • Platelet count ≥ 75,000/mm^3* (transfusion independent)
  • Hemoglobin ≥ 8.0 g/dL* (RBC transfusions allowed)
  • Granulocytopenia, anemia, and/or thrombocytopenia due to bone marrow metastases or extensive prior radiotherapy allowed provided the above hematological criteria are met NOTE: *For patients without bone marrow involvement, including patients who underwent SCT

Hepatic

  • Bilirubin ≤ 3 mg/dL

Renal

  • Creatinine based on age as follows:

    • ≤ .8 mg/dL (for patients age 5 and under)
    • ≤ 1.0 mg/dL (for patients age 6 to 10)
    • ≤ 1.2 mg/dL (for patients age 11 to 15)
    • ≤1.5 mg/dL (for patients age 16 to 21) OR
  • Creatinine clearance or radioisotope glomerular filtration rate > 20 mL/min

Other

  • No uncontrolled seizure disorder
  • No uncontrolled infection
  • CNS toxicity ≤ grade 2
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Recovered from prior immunotherapy
  • At least 7 days since prior anticancer biologic therapy
  • More than 1 week since prior growth factors
  • At least 6 months since prior allogeneic stem cell transplantation

    • No evidence of active graft-vs-host disease
  • No concurrent immunomodulating agents

Chemotherapy

  • Recovered from prior chemotherapy
  • No prior oxaliplatin
  • Prior carboplatin or cisplatin allowed
  • More than 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas)
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • Concurrent dexamethasone for CNS tumors allowed provided patient has been on a stable or decreasing dose for ≥ 1 week before study entry

Radiotherapy

  • Recovered from prior radiotherapy
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 6 months since prior craniospinal radiotherapy
  • At least 6 months since prior radiotherapy to ≥ 50% of the pelvis
  • At least 6 weeks since other prior substantial radiotherapy to the bone marrow
  • Concurrent radiotherapy to localized painful lesions allowed provided ≥ 1 measurable lesion is not irradiated

Surgery

  • Not specified

Other

  • No other concurrent investigational agents
  • No other concurrent anticancer agents
Both
up to 21 Years
No
 
United States,   Australia,   Canada,   New Zealand,   Puerto Rico
 
 
NCT00091182
 
COG-ADVL0421
Children's Oncology Group
National Cancer Institute (NCI)
Study Chair: Orren Beaty, DO, PhD Mission Children's Hospital
Investigator: Marcio A. Malogolowkin, MD Children's Hospital Los Angeles
Investigator: Stacey L. Berg, MD Texas Children's Cancer Center
National Cancer Institute (NCI)
September 2006

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.