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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 4, 2013

Start Date ^ICMJE

January 1997

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00002825 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Docetaxel in Treating Children With Recurrent Solid Tumors

Official Title ^ICMJE

A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS

Brief Summary

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.

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Brain and Central Nervous System Tumors
Neuroblastoma
Sarcoma

Intervention ^ICMJE

Biological: filgrastim
Drug: docetaxel

Study Arm (s)

Experimental: Arm I

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

Interventions:

Biological: filgrastim
Drug: docetaxel

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

December 2004 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Australia, Canada

Administrative Information

NCT Number ^ICMJE

NCT00002825

Other Study ID Numbers ^ICMJE

NCI-2012-02247, CCG-0962, CDR0000065008

Has Data Monitoring Committee

Not Provided

Responsible Party

National Cancer Institute (NCI)

Study Sponsor ^ICMJE

National Cancer Institute (NCI)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Theodore Zwerdling, MD

University of California, Davis

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2006

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

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