Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy
NCT ID: NCT00068289
Last Updated: 2013-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
2003-09-30
2007-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have recurrent or refractory extensive-stage small cell lung cancer that was previously treated with platinum-based chemotherapy (such as cisplatin, carboplatin, or oxaliplatin).
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Detailed Description
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* Determine the efficacy of bortezomib, in terms of response rate (confirmed and unconfirmed, complete and partial), in patients with recurrent or refractory extensive stage small cell lung cancer previously treated with platinum-based therapy.
* Determine the qualitative and quantitative toxic effects of this drug in these patients.
* Determine the overall survival of patients treated with this drug.
* Correlate selected molecular markers with outcomes in patients treated with this drug.
OUTLINE: Patients are stratified according to platinum-sensitivity status (platinum sensitive \[temporarily closed to accrual as of 8/1/04\] vs platinum refractory \[temporarily closed to accrual as of 6/1/04\]).
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per stratum) will be accrued for this study within 0.5-1 year.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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bortezomib
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytologically confirmed extensive stage small cell lung cancer
* Diagnosis by sputum cytology allowed provided it is confirmed by an independent pathologic review
* Clinical evidence of recurrent or refractory disease does not require a confirmatory biopsy
* Measurable disease by plain radiographs, CT scan, or MRI
* Prior radiotherapy to measurable disease allowed provided there is evidence of disease progression by CT scan OR there is measurable disease outside of the radiotherapy field
* Must have received a prior platinum-based chemotherapy regimen and meet criteria for 1 of the following:
* Platinum-sensitive disease, defined as an initial response with subsequent progression more than 90 days after last platinum treatment (temporarily closed to accrual as of 8/1/04)
* Platinum-refractory disease, defined as no response to or progression during platinum treatment or subsequent progression no more than 90 days after last platinum treatment (temporarily closed to accrual as of 6/1/04)
* Brain and/or leptomeningeal metastases are allowed provided all of the following are true:
* Asymptomatic on neurological exam
* No concurrent corticosteroids for symptom control
* No concurrent enzyme-inducing anticonvulsants (e.g., phenytoin or phenobarbital)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Not specified
Renal
* Creatinine no greater than upper limit of normal OR
* Creatinine clearance at least 60 mL/min
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No symptomatic sensory neuropathy greater than grade 1
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any other adequately treated stage I or II cancer currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy
* No concurrent radiotherapy to measurable lesions
Surgery
* At least 14 days since prior thoracic or other major surgery and recovered
* Must have disease outside of the prior surgical resection area OR new lesion must be present
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Principal Investigators
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Primo N. Lara, MD
Role:
University of California, Davis
Angela Davies, MD
Role:
University of California, Davis
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix, Arizona, United States
Veterans Affairs Medical Center - Tucson
Tucson, Arizona, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson, Arizona, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez, California, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa, California, United States
David Grant Medical Center
Travis Air Force Base, California, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, United States
Veterans Affairs Medical Center - Denver
Denver, Colorado, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa, Florida, United States
CCOP - Atlanta Regional
Atlanta, Georgia, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
MBCCOP - University of Illinois at Chicago
Chicago, Illinois, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, United States
CCOP - Central Illinois
Decatur, Illinois, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood, Illinois, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City, Kansas, United States
CCOP - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, United States
Veterans Affairs Medical Center - Lexington
Lexington, Kentucky, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - New Orleans
New Orleans, Louisiana, United States
Veterans Affairs Medical Center - Shreveport
Shreveport, Louisiana, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, United States
Cancer Research Center at Boston Medical Center
Boston, Massachusetts, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States
CCOP - Grand Rapids
Grand Rapids, Michigan, United States
CCOP - Beaumont
Royal Oak, Michigan, United States
Providence Cancer Institute at Providence Hospital
Southfield, Michigan, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Veterans Affairs Medical Center - Jackson
Jackson, Mississippi, United States
CCOP - Kansas City
Kansas City, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
St. Louis University Hospital Cancer Center
St Louis, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
CCOP - Montana Cancer Consortium
Billings, Montana, United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque, New Mexico, United States
MBCCOP - University of New Mexico HSC
Albuquerque, New Mexico, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Veterans Affairs Medical Center - Salisbury
Salisbury, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati, Ohio, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
CCOP - Columbus
Columbus, Ohio, United States
Veterans Affairs Medical Center - Dayton
Dayton, Ohio, United States
CCOP - Dayton
Dayton, Ohio, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Veterans Affairs Medical Center - Charleston
Charleston, South Carolina, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
CCOP - Greenville
Greenville, South Carolina, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, United States
Harrington Cancer Center
Amarillo, Texas, United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, United States
Brooke Army Medical Center
Fort Sam Houston, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Veterans Affairs Medical Center - Houston
Houston, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, United States
Veterans Affairs Medical Center - Temple
Temple, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City, Utah, United States
CCOP - Virginia Mason Research Center
Seattle, Washington, United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, United States
CCOP - Northwest
Tacoma, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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Lara PN Jr, Chansky K, Davies AM, Franklin WA, Gumerlock PH, Guaglianone PP, Atkins JN, Farneth N, Mack PC, Crowley JJ, Gandara DR. Bortezomib (PS-341) in relapsed or refractory extensive stage small cell lung cancer: a Southwest Oncology Group phase II trial (S0327). J Thorac Oncol. 2006 Nov;1(9):996-1001.
Johl J, Chansky K, Lara PN, et al.: The proteasome inhibitor PS-341 (bortezomib) in platinum (plat)-treated extensive-stage small cell lung cancer (E-SCLC): a SWOG (0327) phase II trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-7047, 632s, 2005.
Lara PN Jr, Moon J, Redman MW, Semrad TJ, Kelly K, Allen JW, Gitlitz BJ, Mack PC, Gandara DR. Relevance of platinum-sensitivity status in relapsed/refractory extensive-stage small-cell lung cancer in the modern era: a patient-level analysis of southwest oncology group trials. J Thorac Oncol. 2015 Jan;10(1):110-5. doi: 10.1097/JTO.0000000000000385.
Other Identifiers
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SWOG-S0327
Identifier Type: -
Identifier Source: secondary_id
CDR0000320527
Identifier Type: -
Identifier Source: org_study_id
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