- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00074009
Bortezomib in Treating Patients With Unresectable or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
A Multicenter, Open-Label, Two-Stage, Phase II Study Of PS-341 (LDP-341, NSC # 681239) In Patients With Unresectable Or Metastatic Gastric Adenocarcinoma
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma.
Studieöversikt
Detaljerad beskrivning
OBJECTIVES:
Primary
- Determine the efficacy of bortezomib in patients with unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Secondary
- Determine the toxicity of this drug in these patients.
- Determine possible predictors of response to this drug, using pretreatment tumor immunohistochemistry, in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 15-33 patients will be accrued for this study within 5-12 months.
Studietyp
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Illinois
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Chicago, Illinois, Förenta staterna, 60637-1470
- University of Chicago Cancer Research Center
-
-
New York
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Jamaica, New York, Förenta staterna, 11432
- Queens Cancer Center of Queens Hospital
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New York, New York, Förenta staterna, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792-3236
- University of Wisconsin Comprehensive Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma
- Siewert's class II or III disease
Measurable disease
- At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- No history of known or active brain metastases or primary brain tumors
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100% OR
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 mg/dL
- AST and ALT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No prior cerebrovascular event
- No prior orthostatic hypotension
- No myocardial infarction within the past 6 months
- No peripheral vascular disease requiring surgical management
- No evidence of acute ischemia or significant conduction abnormality by EKG
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 2 months after study participation
- No evidence of peripheral neuropathy
- No prior allergic reaction attributed to compounds of similar chemical or biological composition to bortezomib
- No other malignancy within the past 3 years except basal cell skin cancer, carcinoma in situ of the cervix, or adequately treated nonmetastatic prostate cancer
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study participation
- No other concurrent uncontrolled illness that would preclude study participation
- No other medical condition or reason that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 3 weeks since prior immunotherapy
- No concurrent biological or immunological agents
Chemotherapy
- No more than 1 prior chemotherapy regimen (including adjuvant chemotherapy)
- More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- No concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 3 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- Recovered from all prior therapy
- No other concurrent investigational agents
- No other concurrent anticancer agent or therapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Manish A. Shah, MD, Memorial Sloan Kettering Cancer Center
- Huvudutredare: Gary K. Schwartz, MD, Memorial Sloan Kettering Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Matsmältningssystemets sjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Gastrointestinala sjukdomar
- Magsjukdomar
- Neoplasmer i magen
- Adenocarcinom
- Antineoplastiska medel
- Bortezomib
Andra studie-ID-nummer
- CDR0000341565
- MSKCC-03101
- NCI-6003
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