Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer

• Status: Completed
• Trial end date: 2006-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eisai Inc.
• Treatments: Capecitabine; Irofulven

Criteria

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.