Phase II Trial of Carboplatin and Pemetrexed +/- OGX-427 in Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer
This trial is active, not recruiting.
|Condition||non squamous non small cell lung cancer|
|Sponsor||SCRI Development Innovations, LLC|
|Start date||July 2013|
|End date||September 2015|
|Trial size||155 participants|
|Trial identifier||NCT01829113, SCRI LUN 229|
This randomized phase II study will compare the efficacy and safety of the combination of carboplatin and pemetrexed with and without OGX-427 in patients with previously untreated advanced non-squamous NSCLC.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Denver, CO||Rocky Mountain Cancer Center||no longer recruiting|
|Ft. Myers, FL||Florida Cancer Specialists-South||no longer recruiting|
|Orlando, FL||Florida Hospital Cancer Insitute||no longer recruiting|
|St. Petersburg, FL||Florida Cancer Specialists-North||no longer recruiting|
|Louisville, KY||Baptist Hospital East||no longer recruiting|
|Bethesda, MD||Center for Cancer and Blood Disorders||no longer recruiting|
|Kansas City, MO||Research Medical Center||no longer recruiting|
|Omaha, NE||Nebraska Methodist Hospital||no longer recruiting|
|Morristown, NJ||Hematology-Oncology Associates of Northern NJ||no longer recruiting|
|Cincinnati, OH||Oncology Hematology Care, Inc.||no longer recruiting|
|Columbia, SC||South Carolina Oncology Associates||no longer recruiting|
|Chattanooga, TN||Tennessee Oncology - Chattanooga||no longer recruiting|
|Nashville, TN||Tennessee Oncology||no longer recruiting|
|Fort Worth, TX||The Center for Cancer and Blood Disorders||no longer recruiting|
|Newport News, VA||Peninsula Cancer Institute||no longer recruiting|
|Richmond, VA||Virginia Cancer Institute||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: Every 6 weeks
Overall Response Rate
time frame: Every 6 weeks, projected 32 months.
Safety of the regimen
time frame: Continuous review
time frame: Every 6 weeks, projected 32 months
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Histologic or cytologic diagnosis of advanced NSCLC, excluding squamous cell and small cell histology. Tumors with mixed NSCLC histologies are eligible, as long as the predominant histology is not squamous. If small-cell elements are present or not otherwise specified histologically, the patient is not eligible. 2. Metastatic disease (according to American Joint Committee on Cancer (AJCC) staging system, v7.0). 3. No prior systemic chemotherapy, immunotherapy, targeted therapy, or biological therapy for metastatic disease; adjuvant or neoadjuvant therapy for Stage I, II, or III disease is allowed as long as the interval from the end of treatment until disease progression was >12 months. 4. No prior radiation therapy to the whole pelvis or to ≥25% of the total bone marrow area. Other radiation therapy must be completed at least 2 weeks prior to study entry. Must have recovered from acute adverse effects prior to study entry. 5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 6. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 7. Baseline laboratory values as follows: - Absolute neutrophil count (ANC) ≥1500/μL - Hemoglobin (Hgb) ≥10 g/dL - Platelets ≥100,000/μL - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ≤3.0 x the upper limit of normal (ULN); 5 x ULN if known hepatic metastases. - Total bilirubin ≤1.5 x ULN, unless secondary to Gilbert's disease - Serum creatinine ≤1.5 x ULN. If creatinine is >1.5, calculate creatinine clearance (CrCl) ≥45 mL/min by the Cockcroft-Gault method: Glomerular Filtration Rate (GFR) = (140-age) x (weight/kg) x (0.85 if female)/ (72 x serum creatinine mg/dL) 8. Fertile male patients willing to use adequate contraceptive measures. 9. Female patients who are not of child-bearing potential, and fertile female patients of child-bearing potential who agree to use adequate contraceptive measures, who are not breastfeeding, and who have a negative serum or urine pregnancy test within 72 hours prior to start of randomization. 10. Life expectancy ≥ 12 weeks. 11. Must be ≥18 years of age at the time of consent. 12. Willingness and ability to comply with trial and follow-up procedures. 13. Ability to understand the nature of this trial and give written informed consent. Exclusion Criteria: 1. Known anaplastic lymphoma kinase (ALK) translocation and epidermal growth factor receptor (EGFR) "activating" mutations where first-line treatment with targeted tyrosine kinase inhibitor therapy is more appropriate. 2. Known central nervous system (CNS) disease other than neurologically stable, treated brain metastases defined as metastasis having no evidence of progression or hemorrhage after treatment and no ongoing requirements for corticosteroids, (e.g., dexamethasone) for at least 2 weeks. 3. Any of the following cardiac diseases currently or within the last 6 months as defined by New York Heart Association (NYHA) ≥ Class 2: - Unstable angina pectoris - Congestive heart failure - Acute myocardial infarction - Conduction abnormality not controlled with pacemaker or medication - Significant ventricular or supraventricular arrhythmias (Patients with chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible). 4. Patients currently receiving therapeutic anticoagulation. 5. Pregnant or lactating women. 6. Any serious, active underlying medical condition that would impair the ability of the patient to receive study treatment, such as diabetes mellitus or infection. 7. Unable or unwilling to take folic acid or vitamin B12. 8. Active second malignancy (except non-melanomatous skin or superficial bladder cancer) defined as requiring current need for cancer therapy or at high risk of recurrence during the study. 9. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. 10. Inability or unwillingness to comply with trial and/or follow-up procedures outlined in the protocol.
|Official title||Double-Blind Randomized Phase II Trial of Carboplatin and Pemetrexed With or Without OGX-427 in Patients With Previously Untreated Stage IV Non-Squamous-Non-Small-Cell Lung Cancer (The Spruce Clinical Trial)|
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