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Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
docetaxel
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Alabama at Birmingham Comprehensive Cancer Center
  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
  • Jonsson Comprehensive Cancer Center, UCLA
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Yale Comprehensive Cancer Center
  • University of Miami Sylvester Cancer Center
  • Winship Cancer Institute of Emory University
  • Veterans Affairs Medical Center - Atlanta (Decatur)
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  • Kansas City Cancer Centers - Central
  • Siteman Cancer Center
  • St. Louis University Hospital Cancer Center
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Duke Comprehensive Cancer Center
  • Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
  • Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
  • University of Texas - MD Anderson Cancer Center
  • Huntsman Cancer Institute
  • University of Wisconsin Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Velcade Alone

Velcade plus Docetaxel

Arm Description

Velcade

Velcade plus Docetaxel

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 8, 2003
Last Updated
December 12, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00064012
Brief Title
Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
Official Title
A Randomized, Multicenter, Open-Label, Phase II Study Of VELCADE Alone Or VELCADE Plus Docetaxel In Previously Treated Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary Compare the tumor response rates (complete and partial response) in patients with relapsed or refractory advanced non-small cell lung cancer treated with bortezomib with vs without docetaxel. Secondary Compare time to progression in patients treated with these regimens. Compare the overall and 1-year survival of patients treated with these regimens. Compare the safety and tolerability of these regimens in these patients. Compare the pharmacokinetics and pharmacodynamics of these regimens in these patients. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Arm II: Patients receive docetaxel IV over 1 hour on day 1 and bortezomib IV as in arm I. In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond confirmation of CR. Quality of life is assessed on day 1 of each treatment course (before drug administration) and at 30 days after the completion of study treatment. Patients are followed at 30 days and then every 3 months for survival. PROJECTED ACCRUAL: A total of 155 patients (75 for arm I and 80 for arm II) will be accrued for this study within 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Velcade Alone
Arm Type
Active Comparator
Arm Description
Velcade
Arm Title
Velcade plus Docetaxel
Arm Type
Experimental
Arm Description
Velcade plus Docetaxel
Intervention Type
Drug
Intervention Name(s)
bortezomib
Intervention Type
Drug
Intervention Name(s)
docetaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan H. Schiller, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233-2115
Country
United States
Facility Name
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Yale Comprehensive Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8028
Country
United States
Facility Name
University of Miami Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Veterans Affairs Medical Center - Atlanta (Decatur)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Kansas City Cancer Centers - Central
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Siteman Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis University Hospital Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6868
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-5666
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17075122
Citation
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.
Results Reference
result

Learn more about this trial

Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer

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