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

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ClinicalTrials.gov Identifier: NCT00001387
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: paclitaxel Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Primary Purpose: Treatment
Official Title: Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy
Study Start Date : September 1994
Study Completion Date : July 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001387


Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)

Publications:
ClinicalTrials.gov Identifier: NCT00001387     History of Changes
Other Study ID Numbers: 940204
94-C-0204
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: August 1999

Keywords provided by National Institutes of Health Clinical Center (CC):
Paclitaxel
Pediatric
Pharmacokinetics
Phase I
Toxicity

Additional relevant MeSH terms:
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action