Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510640
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2007-08-01
Brief Title:
Thyroid Cancer and Sunitinib
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Phase 2 of Sunitinib Sutent in Patients With Locally Advanced or Metastatic Anaplastic Differentiated or Medullar Thyroid Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THYSU
Brief Summary:
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during previous studies with sunitinib an angiogenic oncology drug also known as Sutent this study THYSU is justified to evaluate the efficacy of sunitinib in metastatic thyroid carcinoma Furthermore the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine When radioiodine becomes ineffective there is no standard treatment despite some use of chemotherapy
The objective of the trial is to determine the objective tumor response rate efficacy in patients with locally advanced or metastatic anaplastic differentiated or medullary thyroid carcinoma treated with sunitinib a secondary objective is to evaluate the safety of sunitinib in these patients
The THYSU trial is a phase II French multi-center study This trials plan is to enroll 75 patients with locally advanced or metastatic anaplastic differentiated or medullar thyroid carcinoma
The objective of the trial is to determine the objective tumor response rate efficacy in patients with locally advanced or metastatic anaplastic differentiated or medullary thyroid carcinoma treated with sunitinib a secondary objective is to evaluate the safety of sunitinib in these patients
The THYSU trial is a phase II French multi-center study This trials plan is to enroll 75 patients with locally advanced or metastatic anaplastic differentiated or medullar thyroid carcinoma
Detailed Description:
The THYSU trial is a phase II trial of sunitinib Sutent in patients with locally advanced or metastatic anaplastic differentiated or medullary thyroid carcinoma
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during a phase I trial with sunitinib it was justified to evaluate in a prospective trial the efficacy of sunitinib in metastatic thyroid carcinoma Furthermore the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine When radioiodine becomes ineffective there is no standard treatment despite some usage of chemotherapy
The objective of the trial is to determine the objective tumor response rate in patients with locally advanced or metastatic anaplastic differentiated or medullary thyroid carcinoma treated with sunitinib a secondary objective is to evaluate the safety of sunitinib in these patients with thyroid carcinoma
The treatment of sunitinib is the standard dosage and schedule Sunitinib is given orally at the dose of 50 mg daily for 28 days followed by 2 weeks of rest Forthcoming cycles remain identical Modification of the dose may use a lower dose at 375 mg or 25 mg given daily on the same schedule All patients will receive repeated cycles of treatment until disease progression occurrence of unacceptable toxicity withdrawal of patient consent or other withdrawal criteria are met After discontinuation of treatment and the mandated 28-day follow up patients will be followed only in order to collect information on further antineoplastic therapy and survival In patients discontinuing treatment for reasons other than disease progression tumor assessment will continue until disease progression or initiation of other antineoplastic therapies
The more frequent side effects are asthenia mucositis arterial hypertension hand foot syndrome and diarrhea Other side effects have been reported including nausea vomiting cutaneous events decrease in left ventricular ejection fraction neutropenia and thrombopenia
The patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial
Patients must sign and date IRBEC-approved informed consent
Age 18
Patients must have a life expectancy of at least 3 months and Karnofsky performance status 70
Patients must have histologically confirmed TC
Tumor disease must be progressive evidence of disease progression within 6 months
Patients should not be candidates for surgical resection external beam radiotherapy or radioiodine and patients must not have more than one previous systemic treatment for cancer
Patients must have measurable disease defined by RECIST criteria as at least one lesion at least 2 cm in length by conventional CT techniques or at least 1 cm by spiral CT scan
Resolution of all acute toxic effects of any prior treatment to NCI - CTCAE version 30 grade 1
Patients must have discontinued from radiation therapy at least 4 weeks before first dose of study treatment and must have recovered from any toxic effects of treatment
Blood pressure 140 90 mmHg
Patients must have adequate organ function
Patients with reproductive potential must use medically acceptable contraceptive method
Willingness and ability to comply with the study procedures
Patient affiliated with or profiting from a social security system
The presence of any non-inclusion criteria will exclude a patient from study enrollment
Prior to undergoing any specific study procedures patient and investigator sign informed consent During the initial visit including verification of eligibility criteria an interview with the patient is conducted regarding hisher recent and past clinical and treatment history including oncology history Physical examination including examination of major body systems Karnofsky performance status body weight height and vital signs is performed Laboratory data are collected hematology and chemistry coagulation thyroid tests tumor markers and pregnancy test if applicable Para clinic evaluations 12-lead ECGs and tumor imaging are carried out LVEF assessed by Echocardiogram or by MUGA scan if necessary and Brain Naturatic Peptide Or NT pro-BNP test are done
During the follow-up the patients are followed between the end of week 4 and week 6 by clinical and biological evaluation Evaluation of tumor sites under sunitinib is planned every 2 cycles with CT scans For patients with anaplastic or differentiated thyroid carcinoma the first stage will include 21 efficacy-evaluable patients An additional 29 efficacy-evaluable patients will be included at the second stage
For patients with medullary thyroid carcinoma the first stage will include 11 efficacy-evaluable patients An additional 7 to 14 efficacy-evaluable patients will be included at the second stage
10 French Oncology Departments are involved in this trial
Due to arguments showing that angiogenesis could be involved in progression of metastatic thyroid carcinoma and to objective response during a phase I trial with sunitinib it was justified to evaluate in a prospective trial the efficacy of sunitinib in metastatic thyroid carcinoma Furthermore the standard treatment of metastatic thyroid carcinoma when a general treatment is to be prescribed is limited to radioiodine When radioiodine becomes ineffective there is no standard treatment despite some usage of chemotherapy
The objective of the trial is to determine the objective tumor response rate in patients with locally advanced or metastatic anaplastic differentiated or medullary thyroid carcinoma treated with sunitinib a secondary objective is to evaluate the safety of sunitinib in these patients with thyroid carcinoma
The treatment of sunitinib is the standard dosage and schedule Sunitinib is given orally at the dose of 50 mg daily for 28 days followed by 2 weeks of rest Forthcoming cycles remain identical Modification of the dose may use a lower dose at 375 mg or 25 mg given daily on the same schedule All patients will receive repeated cycles of treatment until disease progression occurrence of unacceptable toxicity withdrawal of patient consent or other withdrawal criteria are met After discontinuation of treatment and the mandated 28-day follow up patients will be followed only in order to collect information on further antineoplastic therapy and survival In patients discontinuing treatment for reasons other than disease progression tumor assessment will continue until disease progression or initiation of other antineoplastic therapies
The more frequent side effects are asthenia mucositis arterial hypertension hand foot syndrome and diarrhea Other side effects have been reported including nausea vomiting cutaneous events decrease in left ventricular ejection fraction neutropenia and thrombopenia
The patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial
Patients must sign and date IRBEC-approved informed consent
Age 18
Patients must have a life expectancy of at least 3 months and Karnofsky performance status 70
Patients must have histologically confirmed TC
Tumor disease must be progressive evidence of disease progression within 6 months
Patients should not be candidates for surgical resection external beam radiotherapy or radioiodine and patients must not have more than one previous systemic treatment for cancer
Patients must have measurable disease defined by RECIST criteria as at least one lesion at least 2 cm in length by conventional CT techniques or at least 1 cm by spiral CT scan
Resolution of all acute toxic effects of any prior treatment to NCI - CTCAE version 30 grade 1
Patients must have discontinued from radiation therapy at least 4 weeks before first dose of study treatment and must have recovered from any toxic effects of treatment
Blood pressure 140 90 mmHg
Patients must have adequate organ function
Patients with reproductive potential must use medically acceptable contraceptive method
Willingness and ability to comply with the study procedures
Patient affiliated with or profiting from a social security system
The presence of any non-inclusion criteria will exclude a patient from study enrollment
Prior to undergoing any specific study procedures patient and investigator sign informed consent During the initial visit including verification of eligibility criteria an interview with the patient is conducted regarding hisher recent and past clinical and treatment history including oncology history Physical examination including examination of major body systems Karnofsky performance status body weight height and vital signs is performed Laboratory data are collected hematology and chemistry coagulation thyroid tests tumor markers and pregnancy test if applicable Para clinic evaluations 12-lead ECGs and tumor imaging are carried out LVEF assessed by Echocardiogram or by MUGA scan if necessary and Brain Naturatic Peptide Or NT pro-BNP test are done
During the follow-up the patients are followed between the end of week 4 and week 6 by clinical and biological evaluation Evaluation of tumor sites under sunitinib is planned every 2 cycles with CT scans For patients with anaplastic or differentiated thyroid carcinoma the first stage will include 21 efficacy-evaluable patients An additional 29 efficacy-evaluable patients will be included at the second stage
For patients with medullary thyroid carcinoma the first stage will include 11 efficacy-evaluable patients An additional 7 to 14 efficacy-evaluable patients will be included at the second stage
10 French Oncology Departments are involved in this trial
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-23 | None | None | None |