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

NCT00001387 | Completed Phase 1

• 2 other identifiers: 94020494-C-0204
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms

Keywords

Paclitaxel; Pediatric; Pharmacokinetics; Phase I; Toxicity

Interventions

paclitaxel DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Rowinsky EK, Donehower RC. The clinical pharmacology of paclitaxel (Taxol). Semin Oncol. 1993 Aug;20(4 Suppl 3):16-25.

  PMID: 8102014 BACKGROUND

• 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. doi: 10.1200/JCO.1993.11.11.2127.

  PMID: 7901342 BACKGROUND

• 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. doi: 10.1093/jnci/86.1.18.

  PMID: 7505830 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Paclitaxel

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: December 10, 2002
• Study Start: September 1, 1994
• Study Completion: July 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-08

Locations

US (1)