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Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00124527
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : November 7, 2008
Sponsor:
Information provided by:

July 26, 2005
July 28, 2005
November 7, 2008
March 2005
Not Provided
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
To determine the objective tumor response rate in patients with either anaplastic or locally advanced/metastatic differentiated thyroid cancer treated with irofulven/capecitabine combination therapy.
Complete list of historical versions of study NCT00124527 on ClinicalTrials.gov Archive Site
  • To evaluate the safety of irofulven/capecitabine combination therapy in patients with anaplastic, medullary, or locally advanced/metastatic differentiated thyroid cancer
  • To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response
  • To evaluate the safety of irofulven/capecitabine combination therapy in patients with anaplastic or locally advanced/metastatic differentiated thyroid cancer.
  • To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response.
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Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Thyroid Cancer
Drug: Irofulven + capecitabine
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
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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.

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   France,   Peru,   Russian Federation,   Ukraine,   United States
 
 
NCT00124527
IROF-019
Not Provided
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Eisai Inc.
Not Provided
Not Provided
Eisai Inc.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP