NCT00027716CompletedPhase 2
A Multi-Institutional, Open-Label, Two-Group, Phase II Study of PS-341 (LDP-341, NSC #681239) in Patients With Advanced or Metastatic Sarcoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 12
Study Overview
Brief Summary
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.
Detailed Description
OBJECTIVES:
- Determine the response rate in patients with advanced or metastatic sarcoma treated with bortezomib.
- Correlate levels of cyclins D1, E, p21 (WAF1), p27 (Kip1), mdm^2, p53, and Ki67 with response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease (stratum I: soft tissue sarcoma not specified in stratum II, osteogenic sarcoma arising from soft tissues, or gastrointestinal stromal tumor vs stratum II: Ewing's sarcoma of soft tissue or bone, rhabdomyosarcoma, or osteogenic sarcoma of bone). (Stratum I closed to accrual as of 10/17/03.)
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 3 months for 1 year.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •18 and over
- •Performance status:
- •Karnofsky 80-100% OR
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •AST/ALT no greater than 2.5 times upper limit of normal
- •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
- •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
- +17 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (12)
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