Bethesda, Maryland 20892

  • Neoplasms

Purpose:

The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy.


Study summary:

Paclitaxel is an active antitumor agent that has demonstrated a broad range of activity in preclinical and clinical studies. The optimal dose and schedule has not yet been determined in either adults or children. The objective of this trial is to determine the maximum tolerated dose and the toxicities of paclitaxel given as a short hour infusion in children with refractory malignancy. In addition, the pharmacokinetics of paclitaxel given in this way will be studied and both model-dependent and model-independent parameters will be determined.


Criteria:

DISEASE CHARACTERISTICS: Histologically confirmed cancer (including leukemia) that is: Refractory to standard therapy (objective disease progression required) OR For which no standard therapy exists and patient is ineligible for potentially curative surgery. PRIOR/CONCURRENT THERAPY: Recovery from the toxic effects of prior therapy required. Biologic Therapy: Not specified. Chemotherapy: No prior taxanes. At least 3 weeks since myelosuppressive therapy (6 weeks since nitrosourea). Endocrine Therapy: Not specified. Radiotherapy: Prior extensive craniospinal or pelvic irradiation allowed. Surgery: Ineligible for potential curative surgery. Other: Prior bone marrow transplant allowed. PATIENT CHARACTERISTICS: Age: Over 1 to 21; Performance status: ECOG 0-2; Life expectancy: At least 8 weeks. Hematopoietic: (except with leukemia, bone marrow involvement, history of bone marrow transplantation, or extensive prior radiotherapy). Absolute granulocyte count at least 1,500/mm(3); Platelet count at least 100,000/mm(3); Hemoglobin at least 8.0 g/dL. Hepatic: Bilirubin no greater than 1.5 mg/dL; AST less than 2 times normal. Renal: Creatinine no greater than 1.5 mg/dL OR; Creatinine clearance at least 60 mL/min per square meter. OTHER: No concurrent anticonvulsant therapy. No grade 2 or worse neuropathy. No significant systemic illness (e.g., infection) that could compromise drug excretion or confuse assessment of toxicity. Not pregnant or nursing.


Study is Available At:


Original ID:

940204


NCT ID:

NCT00001387


Secondary ID:

94-C-0204


Study Acronym:


Brief Title:

Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy


Official Title:

Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety Study, Primary Pu


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

25


Enrollment Type:


Study Dates

Start Date:September 1994
Completion Date:July 2000
Verification Date:August 1999
Last Changed Date:March 3, 2008
First Received Date:November 3, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:paclitaxel

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Rowinsky EK, Donehower RC. The clinical pharmacology of paclitaxel (Taxol). Semin Oncol. 1993 Aug;20(4 Suppl 3):16-25. Review.
PMID:8102014
Reference Type:Reference
Citation:Huizing MT, Keung AC, Rosing H, van der Kuij V, ten Bokkel Huinink WW, Mandjes IM, Dubbelman AC, Pinedo HM, Beijnen JH. Pharmacokinetics of paclitaxel and metabolites in a randomized comparative study in platinum-pretreated ovarian cancer patients. J Clin Oncol. 1993 Nov;11(11):2127-35.
PMID:7901342
Reference Type:Reference
Citation:Kohn EC, Sarosy G, Bicher A, Link C, Christian M, Steinberg SM, Rothenberg M, Adamo DO, Davis P, Ognibene FP, et al. Dose-intense taxol: high response rate in patients with platinum-resistant recurrent ovarian cancer. J Natl Cancer Inst. 1994 Jan 5;86(1):18-24.
PMID:7505830

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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