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

Part of paid clinical trials in Hamilton, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT01649947
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Paclitaxel — DRUG
    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)
  • Carboplatin — DRUG
    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 — DRUG
    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.
  • Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 25, 2012
Start date
Dec 23, 2011
Status verified
Oct 2022
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 2: Bevacizumab ineligible patients
    Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Hydroxychloroquine 200 mg PO BID
  • Experimental: Cohort 1: Bevacizumab eligible patients
    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

Primary Outcome Measure

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 [ Time Frame: 6 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Robert Wood Johnson University Hospital at HamiltonHamiltonNew Jersey08690-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-

Find similar trials in Hamilton, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Robert Wood Johnson University Hospital at Hamilton· Hamilton, NJRutgers Cancer Institute of New Jersey· New Brunswick, NJ

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