Clinical trial · Interventional
Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
Phase 2 Clinical Trial of Bi-weekly Dosing of Irofulven Plus Capecitabine in Patients With Anaplastic or Locally Advanced/Metastatic Differentiated Thyroid Cancer
NCT00124527CI-TRIAL-00052301completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irofulven + capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
Secondary outcomes (2)
- measure
- To evaluate the safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer
- measure
- To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.