Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00804830
Recruitment Status : Unknown
Verified August 2012 by Region Skane.
Recruitment status was:  Active, not recruiting
First Posted : December 9, 2008
Last Update Posted : August 21, 2012
Information provided by (Responsible Party):
Region Skane

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.

Condition or disease Intervention/treatment Phase
Thyroid Neoplasms Carcinoma Thyroid Cancer Metastatic Cancer Drug: Bevacizumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
Study Start Date : April 2008
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 2-5 years ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: 2-5 years ]

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Region Skane Identifier: NCT00804830     History of Changes
Other Study ID Numbers: 2007-001783-75
First Posted: December 9, 2008    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Keywords provided by Region Skane:
Anaplastic thyroid cancer

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