Search / Trial NCT00001387

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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

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Trial Information

Current as of October 22, 2024

Completed

Keywords

Paclitaxel Pediatric Pharmacokinetics Phase I Toxicity

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.

Gender

ALL

Eligibility 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.

About National Cancer Institute (Nci)

The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0