- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001387
Phase I and Pharmacokinetic Trial of Paclitaxel (Taxol) Given as a 3-Hour Infusion in Pediatric Patients With Refractory Malignancy
Study Overview
Detailed Description
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Cancer Institute (NCI)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Rowinsky EK, Donehower RC. The clinical pharmacology of paclitaxel (Taxol). Semin Oncol. 1993 Aug;20(4 Suppl 3):16-25.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 940204
- 94-C-0204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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