Docetaxel in Treating Children With Recurrent Solid Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002825
First received: November 1, 1999
Last updated: February 4, 2013
Last verified: May 2006

November 1, 1999
February 4, 2013
January 1997
December 2004   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002825 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Docetaxel in Treating Children With Recurrent Solid Tumors
A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS

Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the response rate to docetaxel in children with recurrent sarcomas, neuroblastomas, or brain tumors.

II. Describe the toxic effects of docetaxel in these patients.

OUTLINE:

All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. Patients are followed for survival.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • Sarcoma
  • Biological: filgrastim
  • Drug: docetaxel
Experimental: Arm I
All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.
Interventions:
  • Biological: filgrastim
  • Drug: docetaxel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
December 2004   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically verified (at original diagnosis) solid tumor that is relapsed or refractory The following histologies are eligible:
  • Sarcomas: Rhabdomyosarcoma Ewing's sarcoma, Peripheral neuroectodermal tumor (PNET), Osteosarcoma, Other soft tissue sarcomas
  • Brain tumors: Ependymoma Primitive neuroectodermal tumor (PNET), High grade astrocytoma, Brain stem glioma (histologic verification not required), Neuroblastoma
  • Measurable disease that can be followed clinically or radiologically required
  • The following not considered measurable: Bone lesions measured by bone scan or bone marrow involvement
  • Central nervous system disease documented by cerebrospinal fluid cytology
  • Pleural effusion

PATIENT CHARACTERISTICS:

  • Age: 21 and under at original diagnosis
  • Performance status: 0-3
  • Life expectancy: Greater than 2 months
  • In the absence of marrow involvement:
  • Absolute neutrophil count at least 1,000/mm3
  • Platelet count at least 100,000/mm3 (transfusion independent)
  • Hemoglobin at least 9.0 g/dL (transfusion allowed)
  • With bone marrow involvement:
  • Absolute neutrophil count at least 750/mm3
  • Red cell and platelet support possible
  • Bilirubin normal
  • ALT/AST less than 1.5 times normal
  • Alkaline phosphatase less than 2.5 times normal
  • Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min
  • Not pregnant or nursing
  • Adequate contraception required of fertile women

PRIOR CONCURRENT THERAPY:

  • Prior bone marrow transplantation allowed:
  • Must have stable engraftment without need for significant blood product support or cytokine therapy
  • No concurrent immunomodulating agents
  • No prior paclitaxel or docetaxel At least 2 weeks since chemotherapy (4 weeks since nitrosoureas)
  • No other concurrent cancer chemotherapy
  • Concurrent corticosteroids allowed for intracranial pressure in brain tumor patients provided patient has been stable for at least 4 weeks
  • Corticosteroids allowed as pretreatment for docetaxel
  • At least 2 months since extensive radiotherapy, defined as:
  • Craniospinal Volume greater than 50% of abdominopelvic cavity
  • Volume greater than one third of lung volume
  • No concurrent radiotherapy
  • No more than 2 prior therapies and fully recovered
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00002825
NCI-2012-02247, CCG-0962, CDR0000065008
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Theodore Zwerdling, MD University of California, Davis
National Cancer Institute (NCI)
May 2006

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