Clinical trial · Interventional
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
A Phase II Study of Bortezomib in Metastatic Papillary Thyroid Carcinoma or Follicular Thyroid Carcinoma
NCT00104871CI-TRIAL-00036168completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insular Thyroid Cancer | Thyroid Gland Neoplasm | PROBABILISTIC | 0.70 |
| Recurrent Thyroid Cancer | Malignant Thyroid Gland Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Follicular Thyroid Cancer | Thyroid Gland Follicular Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Follicular Thyroid Cancer | Thyroid Gland Follicular Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Papillary Thyroid Cancer | Thyroid Gland Papillary Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bortezomib
- description
- Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
- interventionNames
- Drug: Bortezomib
Primary outcomes (2)
- measure
- Objective Tumor Response Rate Assessed by RECIST
- timeFrame
- Baseline to 12 weeks
- description
- Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) =\< 2.5 times upper limit of normal * Bilirubin normal * No symptomatic congestive heart failure * Creatinine normal OR creatinine clearance \>= 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 =\< 6,000 cGy) * At least 6 months since prior radioiodine therapy * No prior external radiotherapy to the measured tumor * Prior thyroidectomy allowed * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational agents * No other concurrent anticancer therapy * Unresponsive to prior radioiodine therapy * Histologically confirmed differentiated thyroid cancer-papillary or follicular type, including, but not limited to, any of the following variants: hurthle cell (oxyphilic), insular, columnar cell, tall cell * Metastatic disease * At least 1 unidimensionally measurable lesion \>= 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
References
Publications (0)
Data not yet available
No reference posted for this study.