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Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2012 by Region Skane.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00804830
First Posted: December 9, 2008
Last Update Posted: August 21, 2012
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.
Information provided by (Responsible Party):
Region Skane
December 8, 2008
December 9, 2008
August 21, 2012
April 2008
December 2012   (Final data collection date for primary outcome measure)
Overall Survival [ Time Frame: 2-5 years ]
Same as current
Complete list of historical versions of study NCT00804830 on ClinicalTrials.gov Archive Site
Response rate [ Time Frame: 2-5 years ]
Same as current
Not Provided
Not Provided
 
Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
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.
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Thyroid Neoplasms
  • Carcinoma
  • Thyroid Cancer
  • Metastatic Cancer
Drug: Bevacizumab
Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
Other Name: Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
Experimental: chemotherapy
Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.
Intervention: Drug: Bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
December 2014
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00804830
2007-001783-75
Yes
Not Provided
Not Provided
Region Skane
Region Skane
Not Provided
Principal Investigator: Jan Tennvall, MD, PhD Dep of Oncology, Lund University Hospital
Region Skane
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP