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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00021242




Trial ID
NCT00021242
Ethics application status
Date submitted
11/07/2001
Date registered
26/01/2003
Date last updated
7/08/2014

Titles & IDs
Public title
Docetaxel in Treating Children With Relapsed or Refractory Acute Lymphoblastic or Acute Myeloid Leukemia
Scientific title
A Phase II Study of Docetaxel (Taxotere) (NSC# 628503, IND# 59,761) in Children With Refractory Leukemias
Secondary ID [1] 0 0
COG-ADVL0023
Secondary ID [2] 0 0
ADVL0023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Response to therapy - 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.
Timepoint [1] 0 0
At any time during protocol therapy

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

Study design
Purpose of the study
Treatment
Allocation to intervention
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
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Alabama
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Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00021242
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janet Franklin, MD, MPH
Address 0 0
Children's Hospital Los Angeles
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