NCT00064012

Brief Summary

RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known whether bortezomib is more effective with or without docetaxel in treating patients with advanced non-small cell lung cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of bortezomib with or without docetaxel in treating patients who have relapsed or refractory stage IIIB or stage IV non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started May 2003

Shorter than P25 for phase_2 lung-cancer

Geographic Reach
1 country

21 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

May 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2003

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
Last Updated

December 13, 2019

Status Verified

March 1, 2013

Enrollment Period

1.2 years

First QC Date

July 8, 2003

Last Update Submit

December 12, 2019

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancer

Study Arms (2)

Velcade Alone

ACTIVE COMPARATOR

Velcade

Drug: bortezomib

Velcade plus Docetaxel

EXPERIMENTAL

Velcade plus Docetaxel

Drug: bortezomibDrug: docetaxel

Interventions

bortezomibDRUG
Velcade AloneVelcade plus Docetaxel
docetaxelDRUG
Velcade plus Docetaxel

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Locally advanced (stage IIIB) or metastatic (stage IV) disease * Inoperable disease * Relapsed or refractory disease * Received 1, and only 1, prior chemotherapy regimen for locally advanced or metastatic disease * Measurable or evaluable disease * No symptomatic or inadequately treated brain metastases * No CNS disease PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * More than 3 months Hematopoietic * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL * Absolute neutrophil count greater than 1,500/mm\^3 Hepatic * AST and ALT less than 3 times upper limit of normal (ULN) * Bilirubin less than 1.5 times ULN * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine less than 1.8 mg/dL Cardiovascular * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart failure * No uncontrolled angina * No severe uncontrolled ventricular arrhythmias * No electrocardiographic evidence of acute ischemia or active conduction system abnormalities * No poorly controlled hypertension Immunologic * No active systemic infection requiring treatment * No prior allergic reaction attributable to compounds containing boron or mannitol * HIV negative Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No peripheral neuropathy grade 2 or greater * No diabetes mellitus * No other serious medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * More than 6 weeks since prior monoclonal antibody therapy * No concurrent routine use of colony-stimulating factors (e.g., filgrastim \[G-CSF\] or sargramostim \[GM-CSF\]) * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * More than 4 weeks since prior chemotherapy * No prior docetaxel * Prior paclitaxel allowed * No other concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids (e.g., prednisone or prednisolone) except dexamethasone as premedication Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * More than 4 weeks since prior major surgery * No concurrent surgery for cancer management or treatment Other * More than 5 years since prior treatment for any other cancer except basal cell skin cancer or carcinoma in situ of the cervix * More than 4 weeks since prior investigational agents * No prior bortezomib * No other concurrent investigational agents * No other concurrent clinical research study participation * No other concurrent antineoplastic therapy * No concurrent routine use of anti-inflammatory drugs, including cyclo-oxygenase inhibitors (e.g., celecoxib or rofecoxib)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (21)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35233-2115, United States

Location

Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095, United States

Location

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Aurora, Colorado, 80010, United States

Location

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

University of Miami Sylvester Cancer Center

Miami, Florida, 33136, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Veterans Affairs Medical Center - Atlanta (Decatur)

Decatur, Georgia, 30033, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

Robbinsdale, Minnesota, 55422, United States

Location

Kansas City Cancer Centers - Central

Kansas City, Missouri, 64111, United States

Location

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

St. Louis University Hospital Cancer Center

St Louis, Missouri, 63110, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center

Nashville, Tennessee, 37232-6868, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-5666, United States

Location

Related Publications (1)

  • Fanucchi MP, Fossella FV, Belt R, Natale R, Fidias P, Carbone DP, Govindan R, Raez LE, Robert F, Ribeiro M, Akerley W, Kelly K, Limentani SA, Crawford J, Reimers HJ, Axelrod R, Kashala O, Sheng S, Schiller JH. Randomized phase II study of bortezomib alone and bortezomib in combination with docetaxel in previously treated advanced non-small-cell lung cancer. J Clin Oncol. 2006 Nov 1;24(31):5025-33. doi: 10.1200/JCO.2006.06.1853.

    PMID: 17075122RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

BortezomibDocetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Boronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsOrganic ChemicalsPyrazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Joan H. Schiller, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2003

First Posted

July 9, 2003

Study Start

May 1, 2003

Primary Completion

July 1, 2004

Study Completion

July 1, 2004

Last Updated

December 13, 2019

Record last verified: 2013-03

Locations

US(21)