- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00025584
PS-341 in Treating Women With Metastatic Breast Cancer
Phase II Trial Of PS-341 In Metastatic Breast Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. Determine the efficacy of PS-341, in terms of response rate, in women with metastatic breast cancer.
SECONDARY OBJECTIVES:
I. Determine the clinical activity of this drug, in terms of progression-free survival, in these women.
II. Determine the toxicity profile and tolerability of this drug in these women.
III. Determine the pharmacodynamics of this drug in these women.
OUTLINE:
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A maximum of 12-35 patients will be accrued for this study within 9-12 months.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- M D Anderson Cancer Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Histologically or cytologically confirmed invasive breast cancer
- Clinical and/or radiological evidence of stage IV disease
- Relapsed or resistant disease within 6-12 months after completion of prior chemotherapy with doxorubicin or epirubicin and/or paclitaxel or docetaxel foradvanced disease or in the adjuvant setting
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- No bone metastases as only measurable site
- Pleural or peritoneal effusions not acceptable as measurable disease
- No known brain metastases
Hormone receptor status:
- Estrogen receptor-negative
- Estrogen receptor-positive
- Female
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
- More than 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Bilirubin normal
- AST or ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No acute ischemia or significant conduction abnormality by EKG
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- LVEF greater than 50%
- No uncontrolled concurrent illness
- No psychiatric illness or social situation that would preclude study
- No ongoing or active infection
- No prior allergic reaction(s) to compounds of similar chemical or biologic composition to PS-341
- No other malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier-method contraception
- See Chemotherapy
- See Disease Characteristics
No more than 1 prior chemotherapy regimen for metastatic disease
- High-dose regimen or bone marrow transplantation considered 1 prior regimen
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- Prior hormonal therapy for metastatic disease or in adjuvant setting allowed
- Prior localized radiotherapy allowed if it does not influence the signal evaluable lesion
- At least 4 weeks since prior radiotherapy and recovered
- At least 2 weeks since prior minor surgery and recovered
- At least 4 weeks since prior major surgery and recovered
- No other concurrent investigational agent
- No other concurrent investigational or commercial agents or therapies to treat this malignancy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Treatment (bortezomib)
Patients receive PS-341 IV over 3-5 seconds twice weekly on weeks 1 and 2. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
|
Korrelativa studier
Givet IV
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Objective tumor response (CR + PR)
Tidsram: Up to 24 months
|
The agent would be of definite interest for further investigation if the associated response rate is at least 30% (p1), and would not be of further interest if the response rate is below 10% (p0).
|
Up to 24 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Time to progression
Tidsram: Up to 3 years
|
Will be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
|
Up to 3 years
|
Overall survival
Tidsram: Up to 3 years
|
Will be reported using the Kaplan-Meier method with 95% confidence intervals indicated.
|
Up to 3 years
|
Correlation between variations in the serum levels of adhesion molecules and angiogenic factors
Tidsram: Up to 24 months
|
Will be evaluated and descriptive analysis will be performed.
|
Up to 24 months
|
Tissue markers of biological activity
Tidsram: Up to 24 months
|
Will be described in case of lesions amenable to tissue biopsy.
The plasma pharmacodynamics of PS-341 as measured by the 20S-proteosome assay, will be used to measured the biological activity of the drug and correlated with response to treatment and variations in biomarkers.
|
Up to 24 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Massimo Cristofanilli, M.D. Anderson Cancer Center
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
Andra studie-ID-nummer
- NCI-2012-02422
- N01CM17003 (U.S.S. NIH-anslag/kontrakt)
- ID00-308
- CDR0000068976 (Registeridentifierare: PDQ (Physician Data Query))
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