Clinical trial NCT00124527: Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Thyroid Cancer
Keywords: Irofulven, Thyroid Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-28
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer.


Eligibility 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.

Primary outcomes:
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:
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
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: Columbus
country: United States
state: Ohio
city: Salta
country: Argentina
city: Lyon
country: France
city: Toulouse
country: France
city: Villejuif
country: France
city: Lima
country: Peru
city: Moscow
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Kiev
country: Ukraine
Study officials:
References: