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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00021242
Registration number
NCT00021242
Ethics application status
Date submitted
11/07/2001
Date registered
27/01/2003
Date last updated
8/08/2014
Titles & IDs
Public title
Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
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Scientific title
A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias
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Secondary ID [1]
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COG-ADVL0023
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Secondary ID [2]
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ADVL0023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - docetaxel
Experimental: Relapsed or Refractory ALL, AML - Docetaxel 60 mg/m\^2 per dose weekly (Days 1,8,15) for 3 weeks followed by 1 week of rest.
Treatment: Drugs: docetaxel
Continuous IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Response to therapy
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Assessment method [1]
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The levels of pro- and anti-apoptotic proteins will be evaluated in specimens taken before and after administration of docetaxel, at the end of therapy and at the time of relapse. The average values and variance of these levels will be used to design further investigations. The pre- and post- docetaxel levels will be compared using the difference of these two values for each patient. The change in level will be assessed using a paired t-test with an appropriate transformation for normality.
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Timepoint [1]
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At any time during protocol therapy
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Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed acute lymphoblastic or acute myeloid leukemia
* M3 bone marrow relapse required
* Refractory to conventional chemotherapy
* No extramedullary disease at relapse
PATIENT CHARACTERISTICS:
Age:
* 21 and under at time of initial diagnosis
Performance status:
* ECOG 0-2
Life expectancy:
* At least 2 months
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* AST and ALT no greater than 1.5 times normal
* Alkaline phosphatase no greater than 2.5 times normal
Renal:
* Creatinine no greater than 1.5 times normal OR
* Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 7 days since prior biologic therapy and recovered
* At least 6 months since prior allogeneic stem cell transplantation
* No concurrent immunomodulating agents during first 2 courses of therapy
* No concurrent routine filgrastim (G-CSF)
Chemotherapy:
* See Disease Characteristics
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
* No prior paclitaxel or docetaxel
* No other concurrent chemotherapy during first 2 courses of therapy
Endocrine therapy:
* No concurrent corticosteroid therapy except dexamethasone, low-dose hydrocortisone to treat allergic reactions, or treatment for adrenal crisis
Radiotherapy:
* Recovered from prior radiotherapy
* At least 2 weeks since prior palliative local radiotherapy
* At least 6 months since prior craniospinal radiotherapy or radiotherapy to at least 50% of the pelvis
* At least 6 weeks since prior substantial bone marrow radiotherapy
* No concurrent radiotherapy
Surgery:
* Not specified
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Minimum age
No limit
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Maximum age
21
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2002
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2006
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Sample size
Target
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Accrual to date
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Final
12
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Recruitment in Australia
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NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Children's Hospital at Westmead - Westmead
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Royal Children's Hospital - Brisbane
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Women's and Children's Hospital - North Adelaide
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Royal Children's Hospital - Parkville
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Princess Margaret Hospital for Children - Perth
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2031 - Randwick
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2145 - Westmead
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4029 - Brisbane
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5006 - North Adelaide
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3052 - Parkville
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Recruitment postcode(s) [6]
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6001 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
Children's Oncology Group
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Address
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Name [1]
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National Cancer Institute (NCI)
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Ethics approval
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children who have relapsed or refractory acute lymphoblastic or acute myeloid leukemia.
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Trial website
https://clinicaltrials.gov/study/NCT00021242
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Trial related presentations / publications
Franklin JL, Seibel NL, Krailo M, Fu C, Adamson PC, Reaman G; Children's Oncology Group. Phase 2 study of docetaxel in the treatment of childhood refractory acute leukemias: a Children's Oncology Group report. Pediatr Blood Cancer. 2008 Mar;50(3):533-6. doi: 10.1002/pbc.21313.
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Public notes
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Contacts
Principal investigator
Name
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Janet Franklin, MD, MPH
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Address
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Children's Hospital Los Angeles
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Franklin JL, Seibel NL, Krailo M, Fu C, Adamson PC...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT00021242
Download to PDF