Clinical trial · Interventional
Bortezomib in Treating Patients With Advanced or Metastatic Sarcoma
A Multi-Institutional, Open-Label, Two-Group, Phase II Study of PS-341 (LDP-341, NSC #681239) in Patients With Advanced or Metastatic Sarcoma
NCT00027716CI-TRIAL-00010638completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Bortezomib may stop the growth of cancer by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have advanced or metastatic sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bortezomib | Drug | Bortezomib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.