Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Region Skane.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
First received: December 8, 2008
Last updated: August 20, 2012
Last verified: August 2012
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.

Condition Intervention Phase
Thyroid Neoplasms
Thyroid Cancer
Metastatic Cancer
Drug: Bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Resource links provided by NLM:

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemotherapy
Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.
Drug: Bevacizumab
Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
Other Name: Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Detailed Description:
Patients with Anaplastic Thyroid Cancer have a poor prognosis. We will treat the patients initially with our standard radiochemotherapy, which consists of doxorubicin 20mg fixed dose/week and hyperfractionated radiotherapy 1,6 Gy twice daily up to 46 Gy in total. The first week during radiotherapy, they will also receive Avastin 15mg/kg. 1-2 weeks after radiotherapy patients will undergo surgery of their primary tumor. After this "standard" therapy patients can be included in this study. Treatment is 20 mg fixed dose doxorubicin q1w and avastin 15mg/kg q3w. Treatment will continue maximum 6 months or until progress or until intolerable side effects occur.

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • PS 3-4 (if pulmonary mets 2-4)
  • R2 resection of primary tumor
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00804830

Jubileumskliniken, Sahlgrenska universitetsjukhuset
Göteborg, Sweden, 413 45
Dep of Oncology, Lund University Hospital
Lund, Sweden, 221 85
Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Region Skane
Principal Investigator: Jan Tennvall, MD, PhD Dep of Oncology, Lund University Hospital
  More Information

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT00804830     History of Changes
Other Study ID Numbers: 2007-001783-75 
Study First Received: December 8, 2008
Last Updated: August 20, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by Region Skane:
Anaplastic thyroid cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Thyroid Carcinoma, Anaplastic
Thyroid Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Head and Neck Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes
Liposomal doxorubicin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2016