Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
NCT ID: NCT00124527
Last Updated: 2021-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
35 participants
INTERVENTIONAL
2005-03-31
2006-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Irofulven + capecitabine
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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Aurora, Colorado, United States
Columbus, Ohio, United States
Salta, , Argentina
Lyon, , France
Toulouse, , France
Villejuif, , France
Lima, , Peru
Moscow, , Russia
Obninsk, , Russia
Kiev, , Ukraine
Countries
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Other Identifiers
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IROF-019
Identifier Type: -
Identifier Source: org_study_id
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