Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00124527
First received: July 26, 2005
Last updated: November 6, 2008
Last verified: November 2008

July 26, 2005
November 6, 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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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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   France,   Peru,   Russian Federation,   Ukraine
 
NCT00124527
IROF-019
Not Provided
Not Provided
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