Lung Cancer Clinical Trial

Bortezomib in Treating Patients With Recurrent or Refractory Extensive-Stage Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

Summary

RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

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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Full Description

OBJECTIVES:

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.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00068289

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 82 Locations for this study

See Locations Near You

MBCCOP - Gulf Coast
Mobile Alabama, 36607, United States
CCOP - Western Regional, Arizona
Phoenix Arizona, 85006, United States
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
Phoenix Arizona, 85012, United States
Veterans Affairs Medical Center - Tucson
Tucson Arizona, 85723, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
Tucson Arizona, 85724, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Veterans Affairs Medical Center - Little Rock (McClellan)
Little Rock Arkansas, 72205, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90033, United States
Veterans Affairs Outpatient Clinic - Martinez
Martinez California, 94553, United States
CCOP - Bay Area Tumor Institute
Oakland California, 94609, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange California, 92868, United States
CCOP - Santa Rosa Memorial Hospital
Santa Rosa California, 95403, United States
David Grant Medical Center
Travis Air Force Base California, 94535, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora Colorado, 80010, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia, 20060, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
MBCCOP - Hawaii
Honolulu Hawaii, 96813, United States
MBCCOP - University of Illinois at Chicago
Chicago Illinois, 60612, United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago Illinois, 60612, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines Illinois, 60141, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
Maywood Illinois, 60153, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
Veterans Affairs Medical Center - Lexington
Lexington Kentucky, 40502, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
Tulane Cancer Center at Tulane University Hospital and Clinic
New Orleans Louisiana, 70112, United States
Veterans Affairs Medical Center - New Orleans
New Orleans Louisiana, 70112, United States
Veterans Affairs Medical Center - Shreveport
Shreveport Louisiana, 71101, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts, 02118, United States
Veterans Affairs Medical Center - Ann Arbor
Ann Arbor Michigan, 48105, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Veterans Affairs Medical Center - Detroit
Detroit Michigan, 48201, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit Michigan, 48202, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
CCOP - Beaumont
Royal Oak Michigan, 48073, United States
Providence Cancer Institute at Providence Hospital
Southfield Michigan, 48075, United States
University of Mississippi Medical Center
Jackson Mississippi, 39216, United States
Veterans Affairs Medical Center - Jackson
Jackson Mississippi, 39216, United States
CCOP - Kansas City
Kansas City Missouri, 64131, United States
St. Louis University Hospital Cancer Center
Saint Louis Missouri, 63110, United States
CCOP - St. Louis-Cape Girardeau
Saint Louis Missouri, 63141, United States
CCOP - Cancer Research for the Ozarks
Springfield Missouri, 65807, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
Veterans Affairs Medical Center - Albuquerque
Albuquerque New Mexico, 87108, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York New York, 10032, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Veterans Affairs Medical Center - Salisbury
Salisbury North Carolina, 28144, United States
CCOP - Southeast Cancer Control Consortium
Winston-Salem North Carolina, 27104, United States
Veterans Affairs Medical Center - Cincinnati
Cincinnati Ohio, 45220, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati Ohio, 45267, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
Veterans Affairs Medical Center - Dayton
Dayton Ohio, 45428, United States
CCOP - Dayton
Dayton Ohio, 45429, United States
Cancer Institute at Oregon Health and Science University
Portland Oregon, 97201, United States
Veterans Affairs Medical Center - Portland
Portland Oregon, 97207, United States
CCOP - Columbia River Oncology Program
Portland Oregon, 97225, United States
Veterans Affairs Medical Center - Charleston
Charleston South Carolina, 29401, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston South Carolina, 29425, United States
CCOP - Greenville
Greenville South Carolina, 29615, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
University of Tennessee Cancer Institute
Memphis Tennessee, 38104, United States
Harrington Cancer Center
Amarillo Texas, 79106, United States
Veterans Affairs Medical Center - Amarillo
Amarillo Texas, 79106, United States
Brooke Army Medical Center
Fort Sam Houston Texas, 78234, United States
University of Texas Medical Branch
Galveston Texas, 77555, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Veterans Affairs Medical Center - Houston
Houston Texas, 77030, United States
University of Texas Health Science Center at San Antonio
San Antonio Texas, 78229, United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio Texas, 78229, United States
Veterans Affairs Medical Center - Temple
Temple Texas, 76504, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
Huntsman Cancer Institute
Salt Lake City Utah, 84112, United States
Veterans Affairs Medical Center - Salt Lake City
Salt Lake City Utah, 84148, United States
CCOP - Virginia Mason Research Center
Seattle Washington, 98101, United States
Veterans Affairs Medical Center - Seattle
Seattle Washington, 98108, United States
CCOP - Northwest
Tacoma Washington, 98405, United States
Madigan Army Medical Center
Tacoma Washington, 98431, United States
Hospital for Sick Children
Toronto Ontario, M5G 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Study ID:

NCT00068289

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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