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Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00804830
First received: December 8, 2008
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Carcinoma
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:

U.S. FDA Resources

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00804830

Locations
Sweden
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
Investigators
Principal Investigator: Jan Tennvall, MD, PhD Dep of Oncology, Lund University Hospital
  More Information

No publications provided

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:
adjuvant
Anaplastic thyroid cancer

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Thyroid Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Neoplastic Processes
 Pathologic Processes
Doxorubicin
Bevacizumab
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on June 17, 2013