Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Region Skane

Status and phase: Terminated; Phase 2

Conditions: Metastatic Cancer; Carcinoma; Thyroid Cancer; Thyroid Neoplasms

Treatments: Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00804830

2007-001783-75

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

chemotherapy

Experimental group

Description:

Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.

Treatment:

Drug: Bevacizumab