Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

NCT01281124 | Completed Phase 2 Results

• 7 other identifiers: NCI-2011-02570CDR0000692184OSU-10100OSU 101008617N01CM00070P30CA016058
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Non-Small Cell Cancer AJCC v7

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 weeks after completion of study treatment

Secondary Outcomes (2)

• Overall Survival

  From the day of initial treatment until death (from any cause), assessed up to 12 weeks after completion of study treatment

• Progression-free Survival

  From the day of initial treatment until documented disease progression (per PET) or death, assessed up to 12 weeks after completion of study treatment

Study Arms (1)

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.

Drug: Azacitidine; Other: Diagnostic Laboratory Biomarker Analysis; Other: Pharmacological Study

Interventions

Azacitidine DRUG

Given subcutaneously

Also known as: 5 AZC, 5-AC, 5-Azacytidine, 5-AZC, Azacytidine, Azacytidine, 5-, Ladakamycin, Mylosar, U-18496, Vidaza

Treatment (azacitidine)

Diagnostic Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (azacitidine)

Pharmacological Study OTHER

Correlative studies

Treatment (azacitidine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Limitations and Caveats

Due to low enrollment of this trial all outcomes were not assessed.

Results Point of Contact

• Title: Greg Otterson
• Organization: The Ohio State University Comprehensive Cancer Center

Greg.Otterson@osumc.edu

614-293-2887

Study Officials

• Gregory A Otterson

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2011
• First Posted: January 21, 2011
• Study Start: January 12, 2011
• Primary Completion: April 15, 2011
• Study Completion: September 12, 2012
• Last Updated: September 24, 2019
• Results First Posted: September 13, 2013

Record last verified: 2019-09

Locations

US (1)