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

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

December 23, 2011

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Non-small Cell Lung CancerAdvanced Non-small Cell Lung CancerRecurrent Non-small Cell Lung Cancer
Interventions
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."

Trial Locations (2)

08690

Robert Wood Johnson University Hospital at Hamilton, Hamilton

08901

Rutgers Cancer Institute of New Jersey, New Brunswick

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Rutgers Cancer Institute of New Jersey

OTHER

lead

Rutgers, The State University of New Jersey

OTHER

NCT01649947 - Modulation of Autophagy in Patients With Advanced/Recurrent Non-small Cell Lung Cancer - Phase II | Biotech Hunter | Biotech Hunter