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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00143533
First received: September 1, 2005
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

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 Intervention Phase
Neoplasm
Diarrhea
Drug: Irinotecan, Cefpodoxime
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Dose limiting toxicities [ Time Frame: September 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: September 2003
Study Completion Date: June 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Drug: Irinotecan, Cefpodoxime
See Detailed description section for treatment details.

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
  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Carlos Rodriguez-Galindo, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00143533     History of Changes
Other Study ID Numbers: CPTCEF
Study First Received: September 1, 2005
Last Updated: September 29, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014