Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Intravenous Irinotecan Using Selective Gastrointestinal Decontamination for Prevention of Diarrhea in Relapsed or Refractory Pediatric Solid Tumors|
- Dose limiting toxicities [ Time Frame: September 2010 ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2003|
|Study Completion Date:||June 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Drug: Irinotecan, Cefpodoxime
See Detailed description section for treatment details.
This is a phase I study with the exploratory investigation of at least four dosage levels (20, 30, 45, 60) to define the tolerable dose for phase II studies. Primary consideration will be given to determinations of the qualitative and quantitative toxicity of the administration of irinotecan with cefpodoxime, and pharmacokinetics of irinotecan when given with cefpodoxime.
Standard phase I escalation study in cohorts of 3-6 patients. Starting level is 20 mg/m2/d, and subsequent levels will be 30 mg/m2/d, 45 mg/m2/d and 60 mg/m2/d. An amendment to the study has included an intermediate level at 40 mg/m2/d.
Irinotecan will be administered as a 60-minute intravenous infusion daily for 5 consecutive days, followed by a 2 day rest, and followed by an additional 5 consecutive days course [(qd x 5) x 2]. Twenty-one days from the first dose will be considered one cycle of therapy. Cefpodoxime will be given orally at 10 mg/kg/day divided BID, starting 2 days prior to the beginning of the first course of irinotecan, and will be continued for the duration of study participation.
Additional objectives include:
- To describe the pharmacokinetics of intravenous irinotecan when given with oral cefpodoxime.
- To describe the dose-limiting toxicity/ies of irinotecan given on the [(qd x 5) x 2] with oral cefpodoxime.
- To evaluate the effect of the administration of oral cefpodoxime on the amount of intestinal beta-glucuronidase.
- To correlate the incidence and severity of diarrhea with the amount of intestinal beta-glucuronidase.
- To describe the toxicities of irinotecan given at doses above 20 mg/m2/d
- To note tumor responses within the confines of a phase I trial
Please refer to this study by its ClinicalTrials.gov identifier: NCT00143533
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Carlos Rodriguez-Galindo, MD||St. Jude Children's Research Hospital|