Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer - Full Text View

Sponsored by:	Region Skane
Information provided by:	Region Skane
ClinicalTrials.gov Identifier:	NCT00804830

Purpose

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.

Condition	Intervention	Phase
Thyroid Neoplasms Carcinoma Thyroid Cancer Metastatic Cancer	Drug: Bevacizumab	Phase II

MedlinePlus related topics: Cancer Thyroid Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Bevacizumab Thyroid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase 2 Study With Avastin and Doxorubicin Postoperatively for Patients With Anaplastic Thyroid Cancer

Further study details as provided by Region Skane:

Primary Outcome Measures:

Overall Survival [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Response rate [ Time Frame: 2-5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
chemotherapy: Experimental Treatment with Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w for 6 months.	Drug: Bevacizumab Avastin 15 mg/kg q3w and doxorubicin 20 mg q1w

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00804830

Contacts

Contact: Jens Engleson, MD	+46-46-177404	jens.engleson@skane.se
Contact: Jan Tennvall, MD	+46-46-177520	jan.tennvall@med.lu.se

Locations

Sweden
Dep of Oncology, Lund University Hospital	Recruiting
Lund, Sweden, 221 85
Principal Investigator: Jens Engleson, MD
Karolinska University Hospital	Recruiting
Stockholm, Sweden, 17176
Contact: Arne Hallqvist, MD arne.hallqvist@karolinska.se
Jubileumskliniken, Sahlgrenska universitetsjukhuset	Recruiting
Göteborg, Sweden, 413 45
Contact: Edvard Abel, MD edvard.abel@oncology.gu.se

Sponsors and Collaborators

Region Skane

Investigators

Principal Investigator:

Jan Tennvall, MD, PhD

Dep of Oncology, Lund University Hospital

More Information

No publications provided

Responsible Party:	Dep of Oncology, Lund University Hospital ( Jan Tennvall )
Study ID Numbers:	2007-001783-75
Study First Received:	December 8, 2008
Last Updated:	December 8, 2008
ClinicalTrials.gov Identifier:	NCT00804830 History of Changes
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Region Skane:

adjuvant
Anaplastic thyroid cancer

Study placed in the following topic categories:

Thyroid Neoplasms
Adjuvants, Immunologic
Endocrine System Diseases
Bevacizumab
Angiogenesis Inhibitors
Doxorubicin
Carcinoma
Anti-Bacterial Agents

Head and Neck Neoplasms
Neoplasm Metastasis
Thyroid Cancer, Anaplastic
Endocrinopathy
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Thyroid Neoplasms
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Endocrine System Diseases
Bevacizumab
Antibiotics, Antineoplastic
Angiogenesis Inhibitors
Pharmacologic Actions
Doxorubicin
Carcinoma

Neoplasms
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Head and Neck Neoplasms
Neoplasm Metastasis
Growth Inhibitors
Angiogenesis Modulating Agents
Thyroid Diseases
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009