Head and Neck CancerPhase 2NCT00100828
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
A Phase 2 study testing irinotecan hydrochloride in people with Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- irinotecan hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2004to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed medullary thyroid cancer
- Metastatic or inoperable locoregional disease
- Measurable disease by CT scan
- 18 years and over
- ECOG PS 0-1
- Adequate lab functions including:
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- Granulocyte count > 1,000/mm^3
- Platelet count > 100,000/mm^3
- Bilirubin < 1.5 mg/dL
- ALT and AST < 2.5 times upper limit of normal
- No unstable or uncompensated hepatic disease
- Creatinine clearance > 60 mL/min
- No unstable or uncompensated renal disease
- Negative pregnancy test
- More than 3 months since prior biologic therapy
- More than 3 months since prior chemotherapy
- No prior radiotherapy to > 25% of bone marrow
- More than 3 months since prior radiotherapy
- Recovered from prior oncologic or other major surgery
- More than 30 days since prior non-approved or investigational drugs
Who cannot join
- Patients with elevated calcitonin levels as the only measurement of disease are not eligible
- Unstable or uncompensated cardiovascular disease
- Unstable or uncompensated respiratory disease
- Pregnant or nursing
- Diarrhea ≥ grade 2 (antidiarrheals allowed)
- Other severe or uncontrolled systemic disease
Show all 9Show fewer
- Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer
- Illness that would preclude study participation
- Significant clinical disorder or laboratory finding that would preclude study participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
About this study
Official title: Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.
Secondary
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
- Conditions
- Head and Neck Cancer
- Being tested
- irinotecan hydrochloride
- Keywords
- thyroid gland medullary carcinoma, recurrent thyroid cancer
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Medullary, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Irinotecan | Experimental | Not described Receives: Drug: irinotecan hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate
To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
Measured: Every 2 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2005 (estimated)
- Study startNov 2004
- Primary completionNov 2008
- Study completionNov 2008
Why it stopped: Closed due to early stopping rule
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Arlene A. Forastiere, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100828
- Sponsor's protocol ID
- J0459
- Other IDs
- P50CA096784, P30CA006973, JHOC-J0459, JHOC-04080402, CDR0000409567, 04-08-04-02
- Status last verified
- Nov 2018
- First submitted
- 6 Jan 2005
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00100828
- Acronym / sponsor ID
- J0459
- Conditions
- Head and Neck Cancer
- Keywords
- thyroid gland medullary carcinoma, recurrent thyroid cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Closed due to early stopping rule
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2004
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 7 Jan 2005 (estimated)
- Results
- Posted 6 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan.
Secondary
- Determine the safety and tolerability of this drug in these patients.
OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses.
PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irinotecan | Experimental | Drug: irinotecan hydrochloride |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed medullary thyroid cancer
- Metastatic or inoperable locoregional disease
- Measurable disease by CT scan
- 18 years and over
- ECOG PS 0-1
Key exclusion criteria (9 listed)
- Patients with elevated calcitonin levels as the only measurement of disease are not eligible
- Unstable or uncompensated cardiovascular disease
- Unstable or uncompensated respiratory disease
- Pregnant or nursing
- Diarrhea ≥ grade 2 (antidiarrheals allowed)
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 hydrochloride | Drug | Irinotecan |
Primary outcome
Response Rate
Time frame: Every 2 cycles
To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial summary from the National Cancer Institute's PDQ® databaseLink 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.
Arlene A. Forastiere, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing irinotecan hydrochloride in people with Head and Neck Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites 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 20 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: stopped early, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Response Rate (time frame: Every 2 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2018.