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- Klinische proef NCT01281124
Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
Pilot Phase II Study of 5-Azacytidine in Previously Treated Patients With Advanced NSCLC
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. To determine the ability of 5-azacytidine to cause DNA hypomethylation and re-expression of silenced tumor suppressor genes when stratified for high or low expression of mir29a, b, and c.
SECONDARY OBJECTIVES:
I. To compare the molecular studies (mir29 expression and tumor suppressor gene methylation) between archival tissue, fresh biopsy pre-treatment samples, and post-treatment fresh samples.
II. To determine the overall response rate by CT (RECIST 1.1 criteria) and PET (EORTC PET response criteria), PFS, and OS of patients treated with azacytidine in the second- or third-line setting.
III. To correlate the blood microRNA profiles (and changes in microRNA profiles) with response to azacytidine.
OUTLINE:
Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo tissue and blood sample collection at baseline and periodically during study treatment for correlative studies. After completion of study treatment, patients are followed up for 12 weeks.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Ohio
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Columbus, Ohio, Verenigde Staten, 43210
- Ohio State University Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
Advanced (stage 4 or recurrent) NSCLC, not eligible for any curative intent treatment
- Tumor must be histologically or cytologically confirmed
- Measurable disease (as defined by RECIST criteria)
Patients may have up to two (and at least one) prior cytotoxic regimens in the metastatic setting
- Prior adjuvant chemotherapy following resection or definitive chemo-radiation for patients with locally advanced disease is not included in this
- Allowable systemic therapy in the metastatic setting includes 2 cytotoxic regimens and erlotinib and/or other non-cytotoxic drugs (i.e., erlotinib, sorafenib, and other tyrosine kinase inhibitors do not count as a "cytotoxic regimen")
- Prior adjuvant therapy or definitive chemo-radiation is allowed if completed > six months before the onset of "first-line" therapy in the metastatic setting - in this setting, adjuvant or definitive chemo-radiation will not "count" as one of the two cytotoxic regimens; if however, the patient relapses within six months from completion of adjuvant or definitive chemoradiation, then this therapy will be considered the first-line cytotoxic therapy
- In the unusual circumstance where patients receive "adjuvant" therapy following resection of oligo-metastatic disease (for example brain metastasis and lung primary resections) and the treating physician decides to administer chemotherapy following all surgery, this will be considered "adjuvant" therapy and the same rules as noted above will apply for initiation of first-line systemic therapy
No patients with uncontrolled brain metastases or leptomeningeal disease
- Patients with controlled brain metastases are allowed
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelets ≥ 100,000 x 10^9/L
- Hemoglobin ≥ 9.0 gm/100 mL
- Total bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 x ULN
- Creatinine ≤ 1.5 mg/dL OR calculated creatinine clearance > 50 mL/min
- No patients who are pregnant
- Women of childbearing potential must have a negative pregnancy test
- The patient must be willing to use adequate contraception for the duration of study treatment and up to four weeks following the last dose of drug
Archival diagnostic material sufficient for microRNA evaluation/assessment is preferred, though optional
- The presence of archival material will not preclude the need for pre and post treatment biopsies
Willing to undergo biopsy pre-treatment and following first cycle
- Biopsy may be from any accessible site (primary or metastatic)
- No known HIV or hepatitis B or C (though testing for this is not required)
No uncontrolled intercurrent illness including, but not limited to:
- Symptomatic CHF
- Unstable angina pectoris
- Serious cardiac arrhythmia
- Serious infection
- Psychiatric illness or social situations that would limit compliance with study requirements
- No patients who have significant psychiatric illness that, in the opinion of the principal investigator, would prevent adequate informed consent or render therapy unsafe
Patients may not have had a prior invasive malignancy except for adequately treated non-melanoma cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 2 years
- For example, a stage 1 (T1c) prostate cancer 2 years prior to a diagnosis of NSCLC would not be exclusionary, however, a metastatic prostate cancer currently receiving hormonal or chemotherapy would be excluded
- No other concurrent palliative radiotherapy
- Recovered from prior surgery, radiation, or chemotherapy to ≤ grade 2 toxicity
- Palliative radiation or surgical procedures (for example, endobronchial therapy) is allowed, but must have been completed > 2 weeks prior to starting treatment
- No other investigational or commercial agents or therapies may be administered with the intent to treat the patient's malignancy
- No other concurrent investigational therapy
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Treatment (azacitidine)
Patients receive azacitidine subcutaneously on days 1-7.
Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
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Correlatieve studies
Correlatieve studies
Given subcutaneously
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29
Tijdsspanne: Up to 12 weeks after completion of study treatment
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The change in mean methylation of the genes between the patients with a low mir29 and a high mir29 expression will be evaluated by a two-sample t-test.
Secondary analyses include a multivariate regression where all 5 changes in methylation will be regressed on mir29 expression (low vs. high) and adjusted for patient demographic and clinical attributes at baseline.
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Up to 12 weeks after completion of study treatment
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall Survival
Tijdsspanne: From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment
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Analyzed using a Kaplan-Meier methods.
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From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment
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Progression-free Survival
Tijdsspanne: From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment
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Analyzed using a Kaplan-Meier methods.
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From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gregory A Otterson, Ohio State University Comprehensive Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van de luchtwegen
- Neoplasmata
- Longziekten
- Neoplasmata per site
- Neoplasmata van de luchtwegen
- Thoracale neoplasmata
- Carcinoom, bronchogeen
- Bronchiale neoplasmata
- Longneoplasmata
- Carcinoom, niet-kleincellige long
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antimetabolieten, antineoplastische
- Antimetabolieten
- Antineoplastische middelen
- Azacitidine
Andere studie-ID-nummers
- NCI-2011-02570 (Register-ID: CTRP (Clinical Trial Reporting Program))
- P30CA016058 (Subsidie/contract van de Amerikaanse NIH)
- N01CM00070 (Subsidie/contract van de Amerikaanse NIH)
- CDR0000692184
- OSU-10100
- OSU 10100 (Andere identificatie: Ohio State University Comprehensive Cancer Center)
- 8617 (Andere identificatie: CTEP)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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