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CompletedNCT00186979Updated Apr 26, 2017

Study of ZD1839 Combined With Irinotecan and Vincristine in Pediatric Patients With Refractory Solid Tumors

A Phase 1 interventional study of Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime. in Solid Tumors, sponsored by St. Jude Children's Research Hospital. Completed at 1 site in United States. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2017-04-26.

Sponsored by St. Jude Children's Research Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
Up to 21 Years
Sex
All
01

Study summary

The purpose of this protocol is to estimate the maximum tolerated dose of gefitinib in combination with fixed dose of irinotecan and vincristine in patients with refractory solid tumors.

Read the detailed description

Objectives of this study are:

  • To determine the dose-limiting toxicities (DLT) of the combination of irinotecan and ZD1839 when given on this schedule.
  • To characterize the pharmacokinetics and pharmacodynamics of gefitinib alone and in combination with irinotecan and vincristine.
  • To estimate the maximum tolerated dose (MTD) of gefitinib in combination with escalating intravenous irinotecan by using selective intestinal decontamination with oral cefixime or cefpodoxime to prevent diarrhea.
  • To estimate the MTD of vincristine (MTD) in combination with gefitinib and irinotecan.

Details of Treatment Interventions

First Cohort:

Standard dose escalation, starting at ZD1839 150 mg/m2/day for 21 days in combination with irinotecan 15mg/m2/day on a daily x 5 for two consecutive week schedule. Dose-limiting diarrhea was seen in this cohort. ZD scheduled was reduced to 12 days. The first dose level (1a) consisted of ZD1839 112.5mg/m2/day for 12 days + irinotecan 15mg/m2/day daily x 5 x 2 and was found to be the MTD in this cohort.

Second Cohort:

Cefixime then added at 4 additional subjects were enrolled at dose level 1c, consisting of ZD1839 at 112mg/m2/day + irinotecan 20mg/m2/day + cefixime 8 mg/kg/day administered once daily, beginning on day -1, and continued to day 14.

Third Cohort:

Irinotecan/ZD1839/Vincristine/Cefixime- Cefixime 8 mg/kg/day administered once daily, beginning on day -1, and continued to day 14, with a maximum dose of 400 mg daily + gefitinib 112.5 mg/m2 orally, daily for 12 days and irinotecan at 15 mg/m2 daily x 5 x 2 +1 mg/m2 (maximum 2mg/dose) on days 1 and 8 with escalating dose of VCR as tolerated.

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Conditions studied

  • Solid Tumors

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Keywords

  • Refractory Childhood Solid Tumors
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In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 34 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

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Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Younger than 22 years of age.
  • Histologic verification of solid tumor malignancy at original diagnosis.
  • Has disease considered refractory to conventional therapy or no conventional therapy exists.
  • Adequate performance status, bone marrow, liver and kidney function.
  • Patients must not have had any previous allergic reactions to penicillin or cephalosporins

Exclusion criteria

Exclusion Criteria:

  • Known severe hypersensitivity to ZD1839 or any of the excipients of this product
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St John's Wort, and CYP3A4 inhibitors
  • Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
  • Incomplete healing from previous oncologic or other major surgery
  • Pregnant or breast-feeding
  • Patients who have an uncontrolled infection
  • Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
  • As judged by the investigator, any evidence of uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease).
  • Evidence of any other significant clinical disorder or laboratory finding that makes is undesirable for the subject to participate in the trial.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Other
    1

    Drug: Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.

Interventions

  • DrugIrinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.

    See Detailed Description section for details of treatment interventions.

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What researchers measure

Primary outcomes

  1. Dose limiting toxicities

    Time frame: Within the first 30 days of completion of first cycle

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Study locations

1 site
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
08

References and documents

Publications

  • A Phase I Study of Gefitinib and irinotecan (IRN) in pediatric patients with refractory solid tumors. WL Furman et al. Vol 22, No 14S (July 15 Supplement), 2004: 8521
  • Effect of Gefitinib on the bioavailability of oral irinotecan in children with refractory solid tumors. K.R. Crews, W.L. Furman, J.C. Panetta, B.B. Freeman, L.C. Iacono, P.J. Houghton, C.F. Stewart. Proceeding of ASCO. Vol 22, No 14S, 2004:2012.
  • Effect of gefitinib on the systemic dispositon of intravenous irinotecan (IRN) in pediatric patients with refractory solid tumors. L.C. Iacono, W.L. Furman, K.R. Crews, J.C. Panetta, B.B. Freeman, N.C. Daw, C.F. Stewart. Proceedings of ASCO. Vol 22, No 14S, 2004:2011.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00186979
Lead sponsor
St. Jude Children's Research Hospital
Collaborators
AstraZeneca, National Institutes of Health (NIH)
Responsible party
Sponsor
First posted
Sep 16, 2005
Start date
May 2003
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Apr 26, 2017

Study contacts

Wayne Furman, M.D.
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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