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A Phase II Trial of PS-341 (NSC-681239) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase II Trial of PS-341 (NSC-681239) in Patients With Platinum-Treated Extensive Stage Small Cell Lung Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Primo N. Lara, MD

Investigator Affiliation:

University of California, Davis

Authority:

United States: Federal Government

Study ID:

CDR0000320527

NCT ID:

NCT00068289

Start Date:

September 2003

Completion Date:

July 2007

Related Keywords:

  • Lung Cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma

Name

Location

University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
MBCCOP - Hawaii Honolulu, Hawaii  96813
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
CCOP - Atlanta Regional Atlanta, Georgia  30342-1701
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Southeast Cancer Control Consortium Winston-Salem, North Carolina  27104-4241
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Huntsman Cancer Institute Salt Lake City, Utah  84112
Veterans Affairs Outpatient Clinic - Martinez Martinez, California  94553
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Santa Rosa Memorial Hospital Santa Rosa, California  95403
David Grant Medical Center Travis Air Force Base, California  94535
CCOP - Central Illinois Springfield, Illinois  62526
Veterans Affairs Medical Center - Lexington Lexington, Kentucky  40511-1093
Veterans Affairs Medical Center - Ann Arbor Ann Arbor, Michigan  48105
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
Veterans Affairs Medical Center - Dayton Dayton, Ohio  45428
CCOP - Dayton Kettering, Ohio  45429
CCOP - Greenville Greenville, South Carolina  29615
Harrington Cancer Center Amarillo, Texas  79106
University of Texas Medical Branch Galveston, Texas  77555-1329
CCOP - Western Regional, Arizona Phoenix, Arizona  85006-2726
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center Orange, California  92868
University of Colorado Cancer Center at University of Colorado Health Sciences Center Denver, Colorado  80010
MBCCOP - University of Illinois at Chicago Chicago, Illinois  60612
CCOP - Grand Rapids Grand Rapids, Michigan  49503
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
MBCCOP - Gulf Coast Mobile, Alabama  36688
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) Phoenix, Arizona  85012
Veterans Affairs Medical Center - Tucson Tucson, Arizona  85723
Veterans Affairs Medical Center - Little Rock (McClellan) Little Rock, Arkansas  72205
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Veterans Affairs Medical Center - Denver Denver, Colorado  80220
Veterans Affairs Medical Center - Chicago (Westside Hospital) Chicago, Illinois  60612
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) Hines, Illinois  60141
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Louisiana State University Health Sciences Center - Shreveport Shreveport, Louisiana  71130-3932
Veterans Affairs Medical Center - Shreveport Shreveport, Louisiana  71130
Veterans Affairs Medical Center - Detroit Detroit, Michigan  48201-1932
Veterans Affairs Medical Center - Jackson Jackson, Mississippi  39216
CCOP - St. Louis-Cape Girardeau Saint Louis, Missouri  63141
Veterans Affairs Medical Center - Albuquerque Albuquerque, New Mexico  87108-5138
Veterans Affairs Medical Center - Cincinnati Cincinnati, Ohio  45220-2288
Veterans Affairs Medical Center - Portland Portland, Oregon  97207
Veterans Affairs Medical Center - Charleston Charleston, South Carolina  29401-5799
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Veterans Affairs Medical Center - Houston Houston, Texas  77030
Veterans Affairs Medical Center - San Antonio (Murphy) San Antonio, Texas  78284
Veterans Affairs Medical Center - Temple Temple, Texas  76504
Veterans Affairs Medical Center - Salt Lake City Salt Lake City, Utah  84148
CCOP - Virginia Mason Research Center Seattle, Washington  98101
Veterans Affairs Medical Center - Seattle Seattle, Washington  98108
CCOP - Northwest Tacoma, Washington  98405-0986
Madigan Army Medical Center Tacoma, Washington  98431-5048
Veterans Affairs Medical Center - New Orleans New Orleans, Louisiana  70112
City of Hope Comprehensive Cancer Center Duarte, California  91010
University of Tennessee Cancer Institute Memphis, Tennessee  38103
Veterans Affairs Medical Center - Amarillo Amarillo, Texas  79106
CCOP - Beaumont Royal Oak, Michigan  48073-6769
Arizona Cancer Center at University of Arizona Health Sciences Center Tucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center Kansas City, Kansas  66160-7353
Markey Cancer Center at University of Kentucky Chandler Medical Center Lexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and Clinic New Orleans, Louisiana  70112
Cancer Research Center at Boston Medical Center Boston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
St. Louis University Hospital Cancer Center Saint Louis, Missouri  63110
Herbert Irving Comprehensive Cancer Center at Columbia University New York, New York  10032
Veterans Affairs Medical Center - Salisbury Salisbury, North Carolina  28144
Cancer Institute at Oregon Health and Science University Portland, Oregon  97201-3098
Hollings Cancer Center at Medical University of South Carolina Charleston, South Carolina  29425
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
Providence Cancer Institute at Providence Hospital Southfield, Michigan  48075