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Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors

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ClinicalTrials.gov Identifier: NCT00143533
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary purpose of this study is to estimate the maximum tolerated dose of irinotecan with the use of cefpodoxime for pediatric solid tumor patients.

Condition or disease Intervention/treatment Phase
Neoplasm Diarrhea Drug: Irinotecan, Cefpodoxime Phase 1

Detailed Description:

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2003
Primary Completion Date : September 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
1 Drug: Irinotecan, Cefpodoxime
See Detailed description section for treatment details.


Outcome Measures

Primary Outcome Measures :
  1. Dose limiting toxicities [ Time Frame: September 2010 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 cephalosporins.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00143533


Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Institutes of Health (NIH)
Investigators
Principal Investigator: Carlos Rodriguez-Galindo, MD St. Jude Children's Research Hospital
More Information

Additional Information:
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00143533     History of Changes
Other Study ID Numbers: CPTCEF
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: September 2011

Keywords provided by St. Jude Children's Research Hospital:
Solid Tumors

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Irinotecan
Camptothecin
Cefpodoxime
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents