Phase 2
N=22
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Insular Thyroid Cancer · Recurrent Thyroid Cancer · Stage II Follicular Thyroid Cancer · Stage II Papillary Thyroid Cancer · Stage IV Follicular Thyroid Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00104871 ↗Enrolled (actual)
22
Serious AEs
77.3%
Results posted
Jun 2014
Primary outcome: Primary: Objective Tumor Response Rate Assessed by RECIST — 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bortezomib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Tumor Response Rate Assessed by RECIST |
— | — |
| PRIMARY Participant Tumor Response Assessed by RECIST |
0; 0; 11; 9 | — |
| SECONDARY Progression-free Survival Assessed by RECIST |
4 | — |
Summary
This phase II trial is studying how well bortezomib works in treating patients with metastatic thyroid cancer that did not respond to radioactive iodine therapy. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Eligibility Criteria
Inclusion Criteria
- The Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%
- Platelet count >= 100,000/mm^3
- Absolute neutrophil count >= 1,500/mm^3
- White Blood Count (WBC) >= 3,000/mm^3
- Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) = = 60 mL/min
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other uncontrolled illness
- At least 4 weeks since prior chemotherapy
- No more than 2 prior chemotherapy regimens
- At least 6 months since prior external beam radiotherapy for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph nodes (dose = = 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- No prior radiotherapy to the only measurable lesion
- No radioiodine uptake in the measured metastatic tumor by radioiodine scan (Note: Must have had >= 1 radioiodine scan since the last radioiodine treatment)
- No known brain metastases
Data sourced from ClinicalTrials.gov (NCT00104871). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.