Bortezomib With or Without Docetaxel in Treating Patients With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT00064012
- Lead Sponsor
- University of Wisconsin, Madison
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Velcade Alone bortezomib Velcade Velcade plus Docetaxel bortezomib Velcade plus Docetaxel Velcade plus Docetaxel docetaxel Velcade plus Docetaxel
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (21)
Blumenthal Cancer Center at Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Siteman Cancer Center
🇺🇸Saint Louis, Missouri, United States
St. Louis University Hospital Cancer Center
🇺🇸Saint Louis, Missouri, United States
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
🇺🇸Los Angeles, California, United States
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
🇺🇸Robbinsdale, Minnesota, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Miami Sylvester Cancer Center
🇺🇸Miami, Florida, United States
Massachusetts General Hospital Cancer Center
🇺🇸Boston, Massachusetts, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas - MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Huntsman Cancer Institute
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham Comprehensive Cancer Center
🇺🇸Birmingham, Alabama, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
🇺🇸Decatur, Georgia, United States
Winship Cancer Institute of Emory University
🇺🇸Atlanta, Georgia, United States
Kansas City Cancer Centers - Central
🇺🇸Kansas City, Missouri, United States
University of Wisconsin Comprehensive Cancer Center
🇺🇸Madison, Wisconsin, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Aurora, Colorado, United States
Yale Comprehensive Cancer Center
🇺🇸New Haven, Connecticut, United States