NCT00186979

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2003

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 26, 2017

Status Verified

October 1, 2011

Enrollment Period

6.8 years

First QC Date

September 12, 2005

Last Update Submit

April 24, 2017

Conditions

Solid Tumors

Keywords

Refractory Childhood Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Dose limiting toxicities

    Within the first 30 days of completion of first cycle

Study Arms (1)

1

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

Interventions

Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.DRUG

See Detailed Description section for details of treatment interventions.

1

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

  • 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

    RESULT

  • 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.

    RESULT

  • 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.

    RESULT

Related Links

MeSH Terms

Interventions

IrinotecanGefitinibVincristineCefiximeCefpodoxime

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsIndolesIndolizidinesIndolizinesCefotaximeCephacetrileCephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur Compounds

Study Officials

  • Wayne Furman, M.D.

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 16, 2005

Study Start

May 1, 2003

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 26, 2017

Record last verified: 2011-10

Locations

US(1)