Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Thyroid Cancer

NCT00004089 | Completed Phase 2

• 4 other identifiers: NU V96N3NU-V96N3UCCRC-08200NCI-G99-1580
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have previously untreated anaplastic thyroid cancer.

Conditions

Head and Neck Cancer

Keywords

anaplastic thyroid cancer

Interventions

filgrastim BIOLOGICAL

fluorouracil DRUG

hydroxyurea DRUG

paclitaxel DRUG

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed anaplastic thyroid cancer Metastatic disease allowed PATIENT CHARACTERISTICS: Age: 15 to 80 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Alkaline phosphatase no greater than 2 times normal Transaminases no greater than 2 times normal Renal: Not specified PRIOR CONCURRENT THERAPY: Prior simple excision (e.g., transoral laser excision) of the primary lesion allowed if organ function preserved Prior modified neck dissection allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Thyroid Carcinoma, Anaplastic

Interventions

Filgrastim; Fluorouracil; Hydroxyurea; Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Urea; Amides; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Therapeutics

Study Officials

• Merrill S. Kies, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: September 14, 2004
• Study Start: August 1, 1999
• Primary Completion: April 1, 2002
• Study Completion: April 1, 2002
• Last Updated: July 10, 2013

Record last verified: 2011-01

Locations

US (3)