Solid TumorsPhase 1NCT00186979
Study of ZD1839 Combined With Irinotecan and Vincristine in Pediatric Patients With Refractory Solid Tumors
A Phase 1 study testing Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime. in people with Solid Tumors, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Mar 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Official title: A Phase I Study of ZD1839 (Iressa) in Combination With Irinotecan (Camptosar or CPT-11) and Vincristine in Pediatric Patients With Refractory Solid Tumors
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.
- Conditions
- Solid Tumors
- Being tested
- Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.
- Keywords
- Refractory Childhood Solid Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.Drug
See Detailed Description section for details of treatment interventions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Not described Receives: Drug: Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities
Measured: Within the first 30 days of completion of first cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Wayne Furman, M.D., Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186979
- Sponsor's protocol ID
- ZD1839
- Status last verified
- Oct 2011
- First submitted
- 12 Sep 2005
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of ZD1839 (Iressa) in Combination With Irinotecan (Camptosar or CPT-11) and Vincristine in Pediatric Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00186979
- Acronym / sponsor ID
- ZD1839
- Conditions
- Solid Tumors
- Keywords
- Refractory Childhood Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca, National Institutes of Health (NIH)
- Study start
- May 2003
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime.See Detailed Description section for details of treatment interventions. | Drug | 1 |
Primary outcome
Dose limiting toxicities
Time frame: Within the first 30 days of completion of first cycle
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Results publicationA 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
- Results publicationEffect 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.
- Results publicationEffect 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.
- St. Jude Children's Research HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wayne Furman, M.D. principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Irinotecan, ZD1839, Vincristine, Cefixime, Cefpodoxime. in people with Solid Tumors, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (time frame: Within the first 30 days of completion of first cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00186979, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.