Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

NCT ID: NCT00804830

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Thyroid Neoplasms; Carcinoma; Thyroid Cancer; Metastatic Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy

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

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Interventions

Bevacizumab

Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Intervention Type: DRUG

Other Intervention Names

Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Tennvall, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dep of Oncology, Lund University Hospital

Locations

Jubileumskliniken, Sahlgrenska universitetsjukhuset

Gothenburg, , Sweden

Dep of Oncology, Lund University Hospital

Lund, , Sweden

Karolinska University Hospital

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2007-001783-75

Identifier Type: -

Identifier Source: org_study_id