NCT00124527

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
6 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2006

Completed
Last Updated

June 16, 2021

Status Verified

November 1, 2008

Enrollment Period

1.4 years

First QC Date

July 26, 2005

Last Update Submit

June 11, 2021

Conditions

Thyroid Cancer

Keywords

Irofulven, Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • 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

Interventions

Irofulven + capecitabineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Unknown Facility

Aurora, Colorado, United States

Location

Unknown Facility

Columbus, Ohio, United States

Location

Unknown Facility

Salta, Argentina

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Toulouse, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Lima, Peru

Location

Unknown Facility

Moscow, Russia

Location

Unknown Facility

Obninsk, Russia

Location

Unknown Facility

Kiev, Ukraine

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

irofulvenCapecitabine

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 28, 2005

Study Start

March 31, 2005

Primary Completion

August 31, 2006

Study Completion

August 31, 2006

Last Updated

June 16, 2021

Record last verified: 2008-11

Locations

FR(3)PE(1)RU(2)US(2)AR(1)UA(1)