Overview

This trial is active, not recruiting.

Conditions thyroid neoplasms, carcinoma, thyroid cancer, metastatic cancer
Treatment bevacizumab
Phase phase 2
Target VEGF
Sponsor Region Skane
Start date April 2008
End date December 2012
Trial size 30 participants
Trial identifier NCT00804830, 2007-001783-75

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.
bevacizumab Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w
Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

Primary Outcomes

Measure
Overall Survival
time frame: 2-5 years

Secondary Outcomes

Measure
Response rate
time frame: 2-5 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer
Principal investigator Jan Tennvall, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by Region Skane.