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Study of Irofulven Plus Capecitabine in Patients With Advanced Thyroid Cancer
This study has been completed.
First Received: July 26, 2005   Last Updated: November 6, 2008   History of Changes
Sponsored by: Eisai Medical Research Inc.
Information provided by: Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT00124527
  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 II

MedlinePlus related topics: Cancer Thyroid Cancer
Drug Information available for: Capecitabine 6-(Hydroxymethyl)acylfulvene Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Eisai Medical Research 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
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 Medical Research Inc.
  More Information

No publications provided

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

Keywords provided by Eisai Medical Research Inc.:
Irofulven, Thyroid Cancer

Study placed in the following topic categories:
Antimetabolites
Capecitabine
Radiation-Sensitizing Agents
Thyroid Neoplasms
Head and Neck Neoplasms
Irofulven
Endocrine System Diseases
Antineoplastic Agents, Alkylating
Endocrinopathy
Alkylating Agents
Thyroid Diseases
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on May 06, 2009