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
  Purpose

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.


Condition Intervention Phase
Thyroid Cancer
Drug: Irofulven + capecitabine
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 35
Study Start Date: March 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124527

Locations
United States, Colorado
Aurora, Colorado, United States
United States, Ohio
Columbus, Ohio, United States
Argentina
Salta, Argentina
France
Lyon, France
Toulouse, France
Villejuif, France
Peru
Lima, Peru
Russian Federation
Moscow, Russian Federation
Obninsk, Russian Federation
Ukraine
Kiev, Ukraine
Sponsors and Collaborators
Eisai Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00124527     History of Changes
Other Study ID Numbers: IROF-019
Study First Received: July 26, 2005
Last Updated: November 6, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Irofulven, Thyroid Cancer

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site
Capecitabine
Irofulven
Alkylating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014