- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00075647
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779.
SECONDARY OBJECTIVES:
I. Determine time to progression, progression-free survival, overall survival, and tumor response rate in patients with measurable disease treated with this drug.
II. Correlate biomarkers of response with clinical response in patients treated with this drug.
III. Determine the safety and toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive CCI-779 IV over 30 minutes once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
Texas
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Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Histologically or cytologically confirmed adenocarcinoma of the pancreas
- Locally advanced or metastatic disease
- Radiographic evidence of disease
- No known brain metastases
- Performance status - ECOG 0-2
- More than 3 months
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)
- Creatinine ≤ 1.5 mg/dL
- Creatinine clearance ≥ 50 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Fasting serum cholesterol ≤ 350 mg/dL
- Fasting triglycerides ≤ 400 mg/dL
- No ongoing or active infection
- No psychiatric illness or social situation that would preclude study compliance
- No other concurrent uncontrolled illness
- No concurrent prophylactic hematopoietic colony-stimulating factors
- No prior chemotherapy for metastatic pancreatic cancer
More than 2 months since prior adjuvant or neoadjuvant chemoradiotherapy for resected pancreatic cancer
- Must have radiographic evidence of recurrent disease
More than 2 months since prior chemoradiotherapy for locally advanced pancreatic cancer
- Must have radiographic evidence of disease progression
- See Chemotherapy
- See Chemotherapy
- No other concurrent investigational or commercial agents or therapies for the malignancy
- No other concurrent anticancer therapy
- No concurrent combination antiretroviral therapy for HIV-positive patients
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes once weekly.
Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
|
Korrelative undersøgelser
Givet IV
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall survival (OS)
Tidsramme: 6 months
|
The method of Thall and Simon will be employed.
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Overall response rate defined as the number of patients who achieved CR or PR divided by the number of patients treated
Tidsramme: Up to 2 years
|
95% confidence interval will be presented
|
Up to 2 years
|
Duration of response
Tidsramme: From the time of objective response to the time of progressive disease, assessed up to 2 years
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From the time of objective response to the time of progressive disease, assessed up to 2 years
|
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Time to progression (TTP)
Tidsramme: From the time of the study entry to the time of relapse or progression, assessed up to 2 years
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From the time of the study entry to the time of relapse or progression, assessed up to 2 years
|
|
Systemic and local adverse events assessed using the established National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Tidsramme: Up to 2 years
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Descriptive statistics (mean, standard deviation, median, and range) will be displayed for relevant laboratory parameters.
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Up to 2 years
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Levels of PTEN, AKT, and PI3K
Tidsramme: Up to 2 years
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Expression levels will be correlated with patient survival duration using Cox proportional hazard regression analysis
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Up to 2 years
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Expression and phosphorylation status of p70s6k
Tidsramme: Up to 7 days
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Descriptive statistics will be applied to report the mean, duration of the effects on p70s6k phosphorylation.
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Up to 7 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Henry Xiong, M.D. Anderson Cancer Center
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Sygdomme i det endokrine system
- Neoplasmer i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Bugspytkirtel neoplasmer
- Lægemidlers fysiologiske virkninger
- Anti-infektionsmidler
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antibakterielle midler
- Antibiotika, antineoplastisk
- Antifungale midler
- Sirolimus
Andre undersøgelses-id-numre
- NCI-2012-02567
- N01CM17003 (U.S. NIH-bevilling/kontrakt)
- MDA-2003-0530
- CDR0000347405 (Registry Identifier: PDQ (Physician Data Query))
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