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


Phase 1
N/A
N/A
Not Enrolling
Both
Neoplasms

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

940204

NCT ID:

NCT00001387

Start Date:

September 1994

Completion Date:

July 2000

Related Keywords:

  • Neoplasms
  • Paclitaxel
  • Pediatric
  • Pharmacokinetics
  • Phase I
  • Toxicity
  • Neoplasms

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892