Recurrent Lung Non-Small Cell CarcinomaPhase 2NCT01281124
Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Azacitidine, Diagnostic Laboratory Biomarker Analysis and Pharmacological Study in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
This phase II clinical trial is studying how well azacitidine works in treating patients with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7
- What is being tested?
- Azacitidine, Diagnostic Laboratory Biomarker Analysis and Pharmacological Study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2011to 12 Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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")
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- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Pilot Phase II Study of 5-Azacytidine in Previously Treated Patients With Advanced NSCLC
This phase II clinical trial is studying how well azacitidine works in treating patients with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Azacitidine, Diagnostic Laboratory Biomarker Analysis, Pharmacological Study
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzacitidineDrug
Also called 5 AZC, 5-AC, 5-Azacytidine, 5-AZC
Given subcutaneously
Diagnostic Laboratory Biomarker AnalysisOther
Correlative studies
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (azacitidine) | Experimental | Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Azacitidine; Other: Diagnostic Laboratory Biomarker Analysis; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29
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.
Measured: Up to 12 weeks after completion of study treatment
Secondary outcomes (2)
Overall Survival
Analyzed using a Kaplan-Meier methods.
Measured: From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment
Progression-free Survival
Analyzed using a Kaplan-Meier methods.
Measured: From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study start12 Jan 2011
- Primary completion15 Apr 2011
- Study completion12 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gregory A Otterson, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281124
- Sponsor's protocol ID
- NCI-2011-02570
- Other IDs
- NCI-2011-02570, CDR0000692184, OSU-10100, OSU 10100, 8617, N01CM00070, P30CA016058
- Status last verified
- Sep 2019
- First submitted
- 20 Jan 2011
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Phase II Study of 5-Azacytidine in Previously Treated Patients With Advanced NSCLC
- ClinicalTrials.gov ID
- NCT01281124
- Acronym / sponsor ID
- NCI-2011-02570
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 12 Jan 2011 (actual)
- Primary completion
- 15 Apr 2011 (actual)
- Study completion
- 12 Sep 2012 (actual)
- First posted
- 21 Jan 2011 (estimated)
- Results
- Posted 13 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II clinical trial is studying how well azacitidine works in treating patients with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (azacitidine) | Experimental | Drug: Azacitidine, Other: Diagnostic Laboratory Biomarker Analysis, Other: Pharmacological StudyPatients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Advanced (stage 4 or recurrent) NSCLC, not eligible for any curative intent treatment
- Measurable disease (as defined by RECIST criteria)
- Patients may have up to two (and at least one) prior cytotoxic regimens in the metastatic setting
- No patients with uncontrolled brain metastases or leptomeningeal disease
- ECOG performance status 0-2
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzacitidineAlso: 5 AZC, 5-AC, 5-Azacytidine, 5-AZCGiven subcutaneously | Drug | Treatment (azacitidine) |
| Diagnostic Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (azacitidine) |
| Pharmacological StudyCorrelative studies | Other | Treatment (azacitidine) |
Primary outcome
DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29
Time frame: Up to 12 weeks after completion of study treatment
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.
2 secondary outcomes
Overall Survival
Time frame: From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment
Progression-free Survival
Time frame: From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory A Otterson principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azacitidine, Diagnostic Laboratory Biomarker Analysis and Pharmacological Study in people with Recurrent Lung Non-Small Cell Carcinoma and Stage IV Lung Non-Small Cell Cancer AJCC v7, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA Hypomethylation and Re-expression of Silenced Tumor Suppressor Genes When Stratified for Low or High Expression of mir29 (time frame: Up to 12 weeks after completion of study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2019.