Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT00729157
Eligibility Criteria:
Inclusion Criteria:
* Histopathologically confirmed differentiated thyroid carcinoma of follicular cell origin, including any of the following histologies and their respective variants:
* Papillary
* Follicular
* Hürthle cell
* Must have surgically inoperable and/or recurrent or metastatic disease
* At least one fludeoxyglucose F 18 (FDG)-PET-avid lesion, defined as any focus of increased FDG uptake \> normal mediastinal activity with standard uptake variable (SUV) maximum levels ≥ 3, as documented by baseline PET scan
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
* Progressive disease, defined by ≥ 1 of the following occurring during or after prior treatment (e.g., radioactive isotope \[RAI\] treatment):
* Presence of new or progressive lesions on CT scan or MRI
* New lesions on bone scan or PET scan
* Rising thyroglobulin level documented by a minimum of 3 consecutive rises, with an interval of \> 1 week between each determination
* No known history of brain metastasis
* ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
* ANC ≥ 1,500/mcL
* Platelet count ≥ 75,000/mcL
* WBC ≥ 3,000/mcL
* Total bilirubin ≤ 1.5 times upper limit of normal(ULN)
* AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN for liver metastases)
* Creatinine ≤ 1.5 times ULNOR creatinine clearance ≥ 60 mL/min
* INR ≤ 1.2 (≤ 1.5 times ULN if on prophylactic-dose anticoagulation)
* Urine protein: creatinine ratio \< 1 OR 24-hour urine protein \< 500 mg
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for ≥ 6 months after completion of study therapy
* Documentation of systolic blood pressure ≤150 mm Hg and diastolic blood pressure ≤100 mm Hg
* No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
* No history of allergic reactions attributed to compounds of similar chemical or biologic composition to other agents used in the study
* No serious or non-healing wound, ulcer, or bone fracture
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess in the past 28 days
* No significant traumatic injury within the past 28 days
* No clinically significant cardiovascular disease, defined as any of the following:
* Cerebrovascular accident within the past 6 months
* Myocardial infarction within the past 6 months
* Coronary artery bypass grafting or unstable angina within the past 6 months
* NYHA grade III-IV congestive heart failure
* Canadian Cardiovascular Class grade III or greater angina within the past 6 months
* Clinically significant peripheral vascular disease within the past 6 months
* Pulmonary embolism, deep-vein thrombosis, or other thromboembolic event within the past 6 months
* Uncontrolled coronary artery disease, angina, congestive heart failure, or ventricular arrhythmia requiring acute medical management
* Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
* No evidence of bleeding diathesis or coagulopathy within the past 12 months
* No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness or social situation that would limit study compliance
* No known HIV positivity
* See Disease Characteristics
* Recovered from prior therapy
* No prior VEGF-targeted antibody therapy (e.g., bevacizumab or aflibercept)
* More than 4 weeks since prior systemic therapy or radiotherapy
* More than 7 days since prior core biopsy
* Up to 1 prior targeted biologic agent (e.g., small-molecule tyrosine kinase inhibitor or histone deacetylase inhibitor) allowed provided treatment was stopped ≥ 4 weeks prior to initiation of therapy on this study
* Up to 1 prior cytotoxic chemotherapy (e.g., doxorubicin hydrochloride) allowed provided treatment was stopped ≥ 4 weeks prior to initiation of therapy on this study
* Prior systemic chemotherapy administered as part of initial definitive treatment (e.g., as a radiation sensitizer or as initial adjuvant therapy) allowed provided treatment was stopped ≥ 3 months prior to initiation of therapy on this study and does not count in the determination of prior targeted or cytotoxic therapy
* At least 2 weeks since prior cyclooxygenase-2 (COX-2) inhibitors, cis-retinoic acid, or complementary medications if given with anti-cancer intent
* Medications given for a specific clinical indication (e.g., daily aspirin status post myocardial infarction or COX-2 inhibitors at standard anti-inflammatory/pain doses) may be continued based on the clinical judgment of the involved investigator
* Prior RAI therapy allowed provided it was stopped \> 3 months prior to initiation of therapy on this protocol and evidence of progression (as defined above) has been documented in the interim
* A diagnostic study using \< 10 mCi of RAI is not considered RAI therapy
* Prior external-beam radiotherapy to index lesions allowed provided there has been documented progression by RECIST criteria and at least 4 weeks have elapsed
* At least 4 weeks since prior external-beam radiation therapy to non-index lesions
* At least 4 weeks since prior surgery
* Concurrent therapeutic-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided that both of the following criteria are met:
* In-range INR appropriate to the treatment indication (e.g., between 2 and 3 for atrial fibrillation) AND on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
* No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
* Patients receiving concurrent antihypertensive agents must have documentation of the date of the last change in dosage
* No other concurrent investigational agents
* No major surgical procedure or open biopsy within the past 28 days
* No anticipation of need for major surgical procedures during the course of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00729157
Study Brief:
Protocol Section:
NCT00729157