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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001387
First received: November 3, 1999
Last updated: March 3, 2008
Last verified: August 1999
  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.


Condition Intervention Phase
Neoplasms
Drug: paclitaxel
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 25
Study Start Date: September 1994
Estimated Study Completion Date: July 2000
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.

  Eligibility

Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00001387

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

Publications:
ClinicalTrials.gov Identifier: NCT00001387     History of Changes
Other Study ID Numbers: 940204, 94-C-0204
Study First Received: November 3, 1999
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014