Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Metastatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00804830
• Other study ID #: 2007-001783-75
• Status: Terminated
• Phase: Phase 2
• Start date: April 2008
• Est. completion date: December 2014

Study information

• Verified date: August 2018
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Metastatic Cancer
• Neoplasm Metastasis
• Thyroid Cancer
• Thyroid Carcinoma, Anaplastic
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Bevacizumab
Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Locations

Country	Name	City	State
Sweden	Jubileumskliniken, Sahlgrenska universitetsjukhuset	Göteborg
Sweden	Dep of Oncology, Lund University Hospital	Lund
Sweden	Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		2-5 years
Secondary	Response rate		2-5 years