Clinical trial NCT00027716 (phase 2, status: completed)
Conditions: sarcoma
ICD codes: C96.A, C46.9, C96.22, C46.0, C46.2, C92.31, C92.32
Drugs: bortezomib
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed sarcoma

          -  Soft tissue metastasis or locally recurrent disease

          -  Stratum I (closed to accrual as of 10/17/03):

               -  Soft tissue sarcoma not specified in stratum II

               -  Osteogenic sarcoma arising from soft tissue or gastrointestinal stromal tumor
                  (GIST)

          -  Stratum II:

               -  Ewing's sarcoma of soft tissue or bone (if measurable soft tissue metastasis is
                  present)

               -  Rhabdomyosarcoma

               -  Osteogenic sarcoma of bone (if measurable soft tissue metastasis is present)

          -  At least 1 unidimensionally measurable lesion

               -  At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

          -  Disease progression within the past 3 months

          -  No prior or active known brain metastases

        PATIENT CHARACTERISTICS:

        Age:

          -  18 and over

        Performance status:

          -  Karnofsky 80-100% OR

          -  ECOG 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:

          -  Bilirubin no greater than 1.5 mg/dL

          -  AST/ALT no greater than 2.5 times upper limit of normal

        Renal:

          -  Creatinine no greater than 1.5 mg/dL OR

          -  Creatinine clearance greater than 60 mL/min

        Cardiovascular:

          -  No peripheral vascular disease requiring surgical management

          -  No history of congestive heart failure even if it is medically controlled

          -  No angina pectoris even if it is medically controlled

          -  No myocardial infarction within the past year

          -  No cardiac arrhythmias

          -  No prior cerebrovascular event

          -  No prior transient ischemic attack

          -  No EKG evidence of acute ischemia or conduction abnormality (e.g., bifascicular block
             [left anterior hemiblock in the presence of right bundle branch block] or second or
             third degree atrioventricular block)

          -  No history of orthostatic hypotension

        Other:

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No prior allergic reaction to compounds of similar chemical or biological composition
             to study drug

          -  No other uncontrolled concurrent illness

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other malignancy within the past 5 years except adequately treated basal cell skin
             cancer or carcinoma in situ of the cervix

          -  No symptomatic peripheral neuropathy greater than grade 1

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  At least 4 weeks since prior immunotherapy and recovered

          -  No concurrent biological or immunological agents

        Chemotherapy:

          -  Stratum I (closed to accrual as of 10/17/03):

               -  At least 1 year since prior chemotherapy in the adjuvant or neoadjuvant setting

               -  No other prior chemotherapy

          -  Stratum II:

               -  No more than 1 prior chemotherapy regimen

          -  No concurrent chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  At least 4 weeks since prior radiotherapy and recovered

          -  No concurrent radiotherapy

        Surgery:

          -  Not specified

        Other:

          -  Prior imatinib mesylate for GIST (stratum I closed to accrual as of 10/17/03) allowed

          -  No other concurrent investigational agents

          -  No concurrent commercial anticancer agents or therapies

          -  No concurrent combination antiretroviral therapy for HIV-positive patients