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Phase I Study of Intravenous Irinotecan Using Selective Gastrointestinal Decontamination for Prevention of Diarrhea in Relapsed or Refractory Pediatric Solid Tumors

Phase 1
20 Years
Not Enrolling
Neoplasm, Diarrhea

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Trial Information

Phase I Study of Intravenous Irinotecan Using Selective Gastrointestinal Decontamination for Prevention of Diarrhea in Relapsed or Refractory Pediatric Solid Tumors

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

Additional objectives include:

- To describe the pharmacokinetics of intravenous irinotecan when given with oral

- 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

- 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

Inclusion Criteria:

- Subjects under 21 years of age at the time of initial diagnosis

- Recurrent solid tumors that have shown to be unresponsive to conventional treatment
for their disease, or subjects with newly diagnosed tumors for whom no conventional
treatment is available

- Histologic verification of solid tumor malignancy at original diagnosis

- Adequate performance status

- Neurologic deficits in subjects with central nervous system (CNS) tumors must have
been relatively stable for a minimum of 2 weeks prior to study entry

- Subjects must have recovered from the toxic effects of all prior chemotherapy before
entering the study

- Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

- No active infection at time of protocol entry, and should not be receiving
antibiotics other than P. carinii pneumonia prophylaxis.

- Patients must not be pregnant or lactating.

- Patients must not be taking an enzyme-inducing anticonvulsant (e.g., phenobarbital,
phenytoin, or carbamazepine), rifampin, or St. John's Wort. Dexamethasone is not to
be used as an antiemetic.

- Patients must not have had any previous allergic reactions to penicillin or

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose limiting toxicities

Outcome Time Frame:

September 2010

Safety Issue:


Principal Investigator

Carlos Rodriguez-Galindo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

September 2003

Completion Date:

June 2011

Related Keywords:

  • Neoplasm
  • Diarrhea
  • Solid Tumors
  • Neoplasms
  • Diarrhea



St. Jude Children's Research Hospital Memphis, Tennessee  38105-2794