Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

NCT00804830 | Terminated Phase 2 DMC

• 1 other identifier: 2007-001783-75
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief Summary

Anaplastic Thyroid Cancer is a very aggressive disease. The investigators believe that angiogenesis is very important for these tumors to progress. Preclinical data is suggesting this. This is why we we prospectively want to treat these patients with avastin (and doxorubicin). However, local control is of major concern. Therefore, patients are initially treated with hyperfractionated radiotherapy and undergo surgery. Then they can enter this study.

Conditions

Thyroid Neoplasms; Carcinoma; Thyroid Cancer; Metastatic Cancer

Keywords

adjuvant; Anaplastic thyroid cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  2-5 years

Secondary Outcomes (1)

• Response rate

  2-5 years

Study Arms (1)

chemotherapy

EXPERIMENTAL

Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Also known as: Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

chemotherapy

Eligibility Criteria

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

You may qualify if:

• cytologically or histologically verified anaplastic thyroid cancer
• completed standard therapy
• operated with R0 or R1 surgery
• Performance Status 0-2 (if pulmonary mets PS 0-1)
• normal wound healing
• neutrophils \> 1,5 million/ml
• platelets \> 100 million/ml
• bilirubin \< 2 ULN
• creatinin \< 150mikromol/L

You may not qualify if:

• PS 3-4 (if pulmonary mets 2-4)
• R2 resection of primary tumor

Sponsors & Collaborators

• Region Skane: lead

Study Sites (3)

Jubileumskliniken, Sahlgrenska universitetsjukhuset

Gothenburg, 413 45, Sweden

Location

Dep of Oncology, Lund University Hospital

Lund, 221 85, Sweden

Location

Karolinska University Hospital

Stockholm, 17176, Sweden

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Carcinoma; Neoplasm Metastasis; Thyroid Carcinoma, Anaplastic

Interventions

Bevacizumab; Doxorubicin

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jan Tennvall, MD, PhD

  Dep of Oncology, Lund University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 9, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

SE (3)