NCT01649947

Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Non-small Cell Lung Cancer
• Advanced Non-small Cell Lung Cancer
• Recurrent Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Paclitaxel	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)
DRUG	Carboplatin	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.
DRUG	Hydroxychloroquine	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.
DRUG	Bevacizumab	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.

Timeline

• Start date: 2011-12-23
• Primary completion: 2015-06-30
• Completion: 2015-06-30
• First posted: 2012-07-25
• Last updated: 2022-11-21
• Results posted: 2019-05-08

Locations

2 sites across 1 country: United States