Status:
COMPLETED
Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Thyroid Gland Carcinoma
Stage III Thyroid Gland Follicular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well aflibercept works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine therapy. Aflibercept may st...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the radiographic response rate (by RECIST criteria) of IV VEGF Trap after four cycles (approximately 8 weeks) of therapy, as well as the 6-month progression-free-s...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00729157
Start Date
August 1 2008
End Date
November 1 2012
Last Update
March 15 2017
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065