| Inclusion Criteria: | 1) Patients may only be enrolled by a Responsible Investigator at one of the 9 Participating Institutions. NTCTCSG Investigators at one of the 5 Non-Participating Institutions may refer patients to a Responsible Investigator at a Participating Institution to facilitate study recruitment.
2) Patients must have histologically confirmed differentiated thyroid carcinoma (papillary or follicular type), including variants including (but not limited to) oxyphilic (Hurthle cell), insular, columnar, and tall cell.
3) Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >=20 mm with conventional techniques or as >=10 mm with spiral CT scan, performed within 4 weeks prior to study enrollment.
4) Patients should not have received chemotherapy within 4 weeks prior to enrollment, and should not have been treated with more than two prior regimens.
5) Patients should not have been treated with external beam radiation to the measured tumor. External beam radiotherapy may have previously been administered for locoregional disease in the thyroid bed, or cervical or upper mediastinal lymph node regions (no more than 6000 cGy), but must have been completed at least 6 months prior to entry.
6) Prior radioiodine therapy is acceptable, but should have been administered at least 6 months prior to enrollment. However, the patient should have had at least one radioiodine scan since the last radioiodine treatment was administered that demonstrated absence of uptake in the measured metastatic tumor. Prior surgical thyroidectomy is acceptable.
7) Age greater than or equal to 18 years. Because no dosing or adverse event data are currently available on the use of bortezomib in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
8) ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%; see Appendix A).
9) Patients must have normal organ and marrow function as defined below: leukocytes greater than or equal to 3,000/uL, absolute neutrophil count greater than or equal to 1,500/uL, platelets greater than or equal to 100,000/uL, total bilirubin not more than institutional upper limit of normal, AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal, creatinine not more than institutional upper limit of normal OR creatinine clearance greater than or equal to 60 mL/min/1.73 m*2 for patients with creatinine levels above institutional normal.
10) The effects of bortezomib on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because proteasome inhibitors may be teratogenic, women of child-bearing potential and men must agree to use contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
11) All patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Patients must have signed an authorization for the release of their protected health information. |