Status:
COMPLETED
Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
Lead Sponsor:
Eisai Inc.
Conditions:
Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 31 2005
Trial Type :
INTERVENTIONAL
End Date :
August 31 2006
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00124527
Start Date
March 31 2005
End Date
August 31 2006
Last Update
June 16 2021
Active Locations (10)
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1
Aurora, Colorado, United States
2
Columbus, Ohio, United States
3
Salta, Argentina
4
Lyon, France