Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00804830

Enrollment

Registered

2008-12-09

Start date

2008-04-30

Completion date

2014-12-31

Last updated

2018-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Metastatic Cancer, Thyroid Cancer, Thyroid Neoplasms

Keywords

adjuvant, Anaplastic thyroid cancer

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.

Interventions

DRUGBevacizumab

Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall Survival	2-5 years

Secondary

Measure	Time frame
Response rate	2-5 years

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026