Clinical trial · Interventional
Docetaxel in Treating Children With Recurrent Solid Tumors
A PHASE II STUDY OF DOCETAXEL (TAXOTERE) (NSC# 628503) IN CHILDREN WITH RECURRENT SOLID TUMORS
NCT00002825CI-TRIAL-00009308completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
| Neuroblastoma | Neuroblastoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- All patients receive docetaxel with G-CSF every 21 days for up to 12 courses.
- interventionNames
- Biological: filgrastim
- Drug: docetaxel
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDBlaney 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. PMID 9193350
- RESULTZwerdling T, Krailo M, Monteleone P, Byrd R, Sato J, Dunaway R, Seibel N, Chen Z, Strain J, Reaman G; Children's Oncology Group. Phase II investigation of docetaxel in pediatric patients with recurrent solid tumors: a report from the Children's Oncology Group. Cancer. 2006 Apr 15;106(8):1821-8. doi: 10.1002/cncr.21779. PMID 16532433