Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Phase 2

Terminated

• Conditions: Metastatic Cancer; Thyroid Neoplasms; Carcinoma; Thyroid Cancer
• Interventions: Drug: Bevacizumab

• Registration Number: NCT00804830
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-12-08
• Study First Submitted QC: 2008-12-08
• Study First Posted: 2008-12-09
• Primary Completion: 2012-12
• Study Completion: 2014-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-24
• Last Update Posted: 2018-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemotherapy	Bevacizumab	Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.

Primary Outcome Measures

Name	Time	Method
Overall Survival	2-5 years

Secondary Outcome Measures

Name	Time	Method
Response rate	2-5 years

Trial Locations

Locations (3)

Jubileumskliniken, Sahlgrenska universitetsjukhuset; 🇸🇪 Göteborg, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Dep of Oncology, Lund University Hospital; 🇸🇪 Lund, Sweden