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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00002825




Registration number
NCT00002825
Ethics application status
Date submitted
1/11/1999
Date registered
1/03/2004
Date last updated
5/02/2013

Titles & IDs
Public title
Docetaxel in Treating Children With Recurrent Solid Tumors
Scientific title
A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS
Secondary ID [1] 0 0
CCG-0962
Secondary ID [2] 0 0
NCI-2012-02247
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain and Central Nervous System Tumors 0 0
Neuroblastoma 0 0
Sarcoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Sarcoma (also see 'Bone') - soft tissue
Cancer 0 0 0 0
Bone
Cancer 0 0 0 0
Neuroendocrine tumour (NET)
Cancer 0 0 0 0
Children's - Other
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - filgrastim
Treatment: Drugs - docetaxel

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


Other interventions: filgrastim


Treatment: Drugs: docetaxel
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
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
Minimum age
No limit
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/1997
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nebraska
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Ohio
Country [15] 0 0
United States of America
State/province [15] 0 0
Oregon
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
Tennessee
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Utah
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
Wisconsin
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Nova Scotia

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00002825
Trial related presentations / publications
Blaney SM, Seibel NL, O'Brien M, Reaman GH, Berg SL, Adamson PC, Poplack DG, Krailo MD, Mosher R, Balis FM. Phase I trial of docetaxel administered as a 1-hour infusion in children with refractory solid tumors: a collaborative pediatric branch, National Cancer Institute and Children's Cancer Group trial. J Clin Oncol. 1997 Apr;15(4):1538-43. doi: 10.1200/JCO.1997.15.4.1538.
Public notes

Contacts
Principal investigator
Name 0 0
Theodore Zwerdling, MD
Address 0 0
University of California, Davis
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00002825