NCT00104871

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2004

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 25, 2014

Completed
Last Updated

December 19, 2018

Status Verified

November 1, 2018

Enrollment Period

5.4 years

First QC Date

March 3, 2005

Results QC Date

November 20, 2013

Last Update Submit

November 30, 2018

Conditions

Insular Thyroid CancerRecurrent Thyroid CancerStage II Follicular Thyroid CancerStage II Papillary Thyroid CancerStage IV Follicular Thyroid CancerStage IV Papillary Thyroid Cancer

Keywords

National Thyroid Cancer Treatment Cooperative Study GroupNTCTCSGbortezomibvelcademetastatic differentiated thyroid carcinomaDifferentiated thyroid carcinomafollicular epithelial thyroid cellspapillaryoxyphilic cellHurthle cellinsular cellcolumnar celltall cell

Outcome Measures

Primary Outcomes (2)

  • Objective Tumor Response Rate Assessed by RECIST

    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.

    Baseline to 12 weeks

  • Participant Tumor Response Assessed by RECIST

    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.

    Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))

Secondary Outcomes (1)

  • Progression-free Survival Assessed by RECIST

    At 6 months

Study Arms (1)

Bortezomib

EXPERIMENTAL

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.

Drug: Bortezomib

Interventions

BortezomibDRUG

Administered IV at the dose of 1.3 mg/m\^2 on a twice-weekly schedule for 2 consecutive weeks on days 1, 4, 8, and 11, followed by a 10 day rest period on days 12-21 (one cycle). In the absence of clinical progression, treatment continued for a minimum of 4 treatment cycles (or 12 weeks).

Also known as: LDP 341, MLN341, VELCADE
Bortezomib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University of Colorado at Denver Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University

Washington D.C., District of Columbia, 20057, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Harvard Cancer Center

Boston, Massachusetts, 02115, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Thyroid NeoplasmsAdenocarcinoma, FollicularThyroid Cancer, Papillary

Interventions

Bortezomib

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeAdenocarcinoma, Papillary

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Steven Sherman, MD / Professor
Organization
UT MD Anderson Cancer Center
sisherma@mdanderson.org
713-792-2841

Study Officials

  • Steven Sherman

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

December 1, 2004

Primary Completion

May 1, 2010

Study Completion

April 1, 2014

Last Updated

December 19, 2018

Results First Posted

June 25, 2014

Record last verified: 2018-11

Locations

US(9)