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).
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.
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 82 Locations for this study
Mobile Alabama, 36607, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85012, United States
Tucson Arizona, 85723, United States
Tucson Arizona, 85724, United States
Little Rock Arkansas, 72205, United States
Little Rock Arkansas, 72205, United States
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Martinez California, 94553, United States
Oakland California, 94609, United States
Orange California, 92868, United States
Santa Rosa California, 95403, United States
Travis Air Force Base California, 94535, United States
Aurora Colorado, 80010, United States
Denver Colorado, 80220, United States
Washington District of Columbia, 20060, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30342, United States
Honolulu Hawaii, 96813, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60612, United States
Decatur Illinois, 62526, United States
Hines Illinois, 60141, United States
Maywood Illinois, 60153, United States
Kansas City Kansas, 66160, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67218, United States
Lexington Kentucky, 40502, United States
Lexington Kentucky, 40536, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
New Orleans Louisiana, 70112, United States
Shreveport Louisiana, 71101, United States
Shreveport Louisiana, 71130, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48105, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Grand Rapids Michigan, 49503, United States
Royal Oak Michigan, 48073, United States
Southfield Michigan, 48075, United States
Jackson Mississippi, 39216, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64131, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63141, United States
Springfield Missouri, 65807, United States
Billings Montana, 59101, United States
East Orange New Jersey, 07018, United States
Albuquerque New Mexico, 87108, United States
Albuquerque New Mexico, 87131, United States
New York New York, 10016, United States
New York New York, 10032, United States
Rochester New York, 14642, United States
Salisbury North Carolina, 28144, United States
Winston-Salem North Carolina, 27104, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43206, United States
Dayton Ohio, 45428, United States
Dayton Ohio, 45429, United States
Portland Oregon, 97201, United States
Portland Oregon, 97207, United States
Portland Oregon, 97225, United States
Charleston South Carolina, 29401, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29615, United States
Spartanburg South Carolina, 29303, United States
Memphis Tennessee, 38104, United States
Amarillo Texas, 79106, United States
Amarillo Texas, 79106, United States
Fort Sam Houston Texas, 78234, United States
Galveston Texas, 77555, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Temple Texas, 76504, United States
Temple Texas, 76508, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84148, United States
Seattle Washington, 98101, United States
Seattle Washington, 98108, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98431, United States
Toronto Ontario, M5G 1, Canada
How clear is this clinincal trial information?
Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.