Thyroid CancerPhase 2NCT00124527
Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
A Phase 2 study testing Irofulven + capecitabine in people with Thyroid Cancer, run by Eisai Inc. at 10 sites in 6 countries.
Trial summary
Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer
- What is being tested?
- Irofulven + capecitabine
- How many people
- 35 participants
- Where
- 10 sitesin 6 countries
- Study dates
- 31 Mar 2005to 31 Aug 2006
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older.
- Cancer of the thyroid confirmed by a biopsy sample. Specific types of thyroid cancer included in this study are anaplastic, differentiated (papillary, follicular, or Hürthle cell), and medullary thyroid cancers.
- For patients with differentiated (papillary, follicular, or Hürthle cell) thyroid cancer, no more than 1 prior chemotherapy treatment is allowed.
- Measurable disease is required (at least one lesion at least 2 cm in length by conventional computed tomography (CT) techniques or at least 1 cm by spiral CT scan).
- Any prior chemotherapy or radiation therapy must be stopped at least 4 weeks before the first dose of study treatment. Prior radioiodine (I131) therapy must be stopped at least 3 (or 6) months before first dose of study treatment (depending on responsiveness to this therapy).
- Recovery from any toxic effects of prior chemotherapy, radiation therapy and surgery.
- Patients with reproductive potential must use a medically acceptable contraceptive method. Women of childbearing potential must have a negative pregnancy test at screening.
Who cannot join
- History of retinopathy.
- Serious ongoing medical or psychiatric disorder (as determined by the clinical investigator).
- External beam radiation therapy to >30% of the bone marrow at any time prior to study entry.
- Prior treatment with irofulven or capecitabine, or protracted infusion of 5-fluorouracil (5-FU) (infusion duration greater than or equal to 5 days) or other fluoropyrimidines.
- Therapeutic doses of coumarin derivatives (warfarin) 14 days prior to receiving the first dose of study treatment or during the study period.
- Please note: There are additional criteria that must be met in order to be eligible for this study.
Trial locations and contacts
10 sites in 6 countries.
10 sites in 6 countries
United States2 sites
Study site
Aurora, Colorado
Study site
Columbus, Ohio
About this study
Official title: Phase 2 Clinical Trial of Bi-weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer
Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.
- Conditions
- Thyroid Cancer
- Being tested
- Irofulven + capecitabine
- Keywords
- Irofulven, Thyroid Cancer
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irofulven + capecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the objective tumor response rate in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer treated with irofulven/capecitabine combination therapy
Secondary outcomes (2)
To evaluate the safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer
To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study start31 Mar 2005
- Primary completion31 Aug 2006
- Study completion31 Aug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124527
- Sponsor's protocol ID
- IROF-019
- Status last verified
- Nov 2008
- First submitted
- 26 Jul 2005
- Last updated
- 16 Jun 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Clinical Trial of Bi-weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer
- ClinicalTrials.gov ID
- NCT00124527
- Acronym / sponsor ID
- IROF-019
- Conditions
- Thyroid Cancer
- Keywords
- Irofulven, Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2005 (actual)
- Primary completion
- 31 Aug 2006 (actual)
- Study completion
- 31 Aug 2006 (actual)
- First posted
- 28 Jul 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.
Irofulven is an investigational chemotherapeutic agent being studied in a variety of solid tumors. The purpose of this study is to assess the efficacy and safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older.
- Cancer of the thyroid confirmed by a biopsy sample. Specific types of thyroid cancer included in this study are anaplastic, differentiated (papillary, follicular, or Hürthle cell), and medullary thyroid cancers.
- For patients with differentiated (papillary, follicular, or Hürthle cell) thyroid cancer, no more than 1 prior chemotherapy treatment is allowed.
- Measurable disease is required (at least one lesion at least 2 cm in length by conventional computed tomography (CT) techniques or at least 1 cm by spiral CT scan).
- Any prior chemotherapy or radiation therapy must be stopped at least 4 weeks before the first dose of study treatment. Prior radioiodine (I131) therapy must be stopped at least 3 (or 6) months before first dose of study treatment (depending on responsiveness to this therapy).
Key exclusion criteria (6 listed)
- History of retinopathy.
- Serious ongoing medical or psychiatric disorder (as determined by the clinical investigator).
- External beam radiation therapy to >30% of the bone marrow at any time prior to study entry.
- Prior treatment with irofulven or capecitabine, or protracted infusion of 5-fluorouracil (5-FU) (infusion duration greater than or equal to 5 days) or other fluoropyrimidines.
- Therapeutic doses of coumarin derivatives (warfarin) 14 days prior to receiving the first dose of study treatment or during the study period.
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 |
|---|---|---|
| Irofulven + capecitabine | Drug | – |
Primary outcome
To determine the objective tumor response rate in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer treated with irofulven/capecitabine combination therapy
2 secondary outcomes
To evaluate the safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer
To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response
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 16 Jun 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irofulven + capecitabine in people with Thyroid Cancer, run by Eisai Inc. at 10 sites in 6 countries.
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 7 inclusion and 6 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 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, United States, Russia, Argentina, Peru and 1 more country. 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?
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?
To determine the objective tumor response rate in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer treated with irofulven/capecitabine combination therapy. 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 16 Jun 2021.