- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00027716
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
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.
Studienübersicht
Detaillierte Beschreibung
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.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for stratum I within 5-11 months and 21-41 patients will be accrued for stratum II within 10.5-22 months. (Stratum I closed to accrual as of 10/17/03.)
Studientyp
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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Colorado
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Aurora, Colorado, Vereinigte Staaten, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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New York
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Bronx, New York, Vereinigte Staaten, 10461
- Albert Einstein College Of Medicine
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New York, New York, Vereinigte Staaten, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Vereinigte Staaten, 10021
- University of Chicago Cancer Research Center
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Pennsylvania
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Philadelphia, Pennsylvania, Vereinigte Staaten, 19104-4283
- Abramson Cancer Center at University of Pennsylvania Medical Center
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Maskierung: Keine (Offenes Etikett)
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienstuhl: Robert Maki, MD, PhD, Memorial Sloan Kettering Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
- Weichteilsarkom im Stadium IV bei Erwachsenen
- rezidivierendes Weichteilsarkom bei Erwachsenen
- erwachsenes Rhabdomyosarkom
- metastasierendes Ewing-Sarkom/peripherer primitiver neuroektodermaler Tumor
- rezidivierendes Ewing-Sarkom/peripherer primitiver neuroektodermaler Tumor
- metastasierendes Osteosarkom
- rezidivierendes Osteosarkom
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 01-073
- CDR0000069060 (Registrierungskennung: PDQ (Physician Data Query))
- NCI-1757
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