Modulation of Autophagy With Hydroxychloroquine in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - a Phase II Study. A Study of The Cancer Institute of New Jersey Oncology Group (CINJOG)
Sponsor study identifier
Secondary identifiers
OTHER · UMDNJ IRB Number
NIH
OTHER · CTRP (Clinical Trials Reporting System)
OTHER · Rutgers Cancer Institute of New Jersey
interventional
32
1 country
2
Study Start
December 23, 2011
Actual (reported)Primary Completion
June 30, 2015
Actual (reported)Study Completion
June 30, 2015
Actual (reported)The purpose of this study is to examine the combination of one standard treatment for lung cancer plus an additional drug, hydroxychloroquine. The standard treatment for lung cancer being used includes 2 chemotherapy drugs, called paclitaxel and carboplatin. Some patients who have a specific type of lung cancer can also receive another drug, a drug that targets blood vessels, called bevacizumab (also known as avastin). Hydroxychloroquine is an FDA approved drug for the treatment of malaria, rheumatoid arthritis and lupus erythematosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 23, 2011
Actual (reported)July 20, 2012
Actual (reported)July 25, 2012
Actual (reported)June 30, 2015
Actual (reported)June 30, 2015
Actual (reported)May 8, 2019
Actual (reported)Antitumor Activity, as Measured by Tumor Response Rate of Hydroxychloroquine, Paclitaxel, Carboplatin, and Bevacizumab (for Eligible Patients) in Patients With Advanced or Recurrent NSCLC Cancer
Assessed using RECIST criteria. Determined using a Simon's two-stage minimax design with a 5% significance level and 80% power.
6 years
Progression Free Survival (PFS)
6 years
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID
Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for Hydroxychloroquine 200 mg PO BID
Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1). Cycles every 3 weeks for 4-6 Cycles. Prior to receiving paclitaxel, all patients will receive the following premedication: * Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv \< 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone) * Diphenydramine 50 mg iv (or equivalent) \< 1 hour prior to paclitaxel infusion * Ranitidine 50 mg iv \< 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)
Robert Wood Johnson University Hospital at Hamilton
Hamilton, New Jersey, 08690, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Joseph Aisner, MD
Rutgers Cancer Institute of New Jersey
32 participants (actual enrollment reported by the registry).
First Submitted
July 20, 2012
First Posted
July 25, 2012
Study Start
December 23, 2011
Actual (reported)Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily dose of 400 mg). Cycles every 3 weeks for 4-6 Cycles.
Cohort 1 only: Bevacizumab will be given by IV on Day 1 of each 21-day cycle at a dose of 15 mg/kg. Cycles every 3 weeks for 4-6 Cycles.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 30, 2015
Actual (reported)Study Completion
June 30, 2015
Actual (reported)Last Updated
November 21, 2022
Results First Posted
May 8, 2019
Record last verified: 2022-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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