Clinical trial NCT00068289 (phase 2, status: completed)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
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