Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors
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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 |
- 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 |
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| 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 |
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:
|
Neoplasms Diarrhea Signs and Symptoms, Digestive Signs and Symptoms Cefpodoxime Cefpodoxime proxetil Irinotecan Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013