Hydroxychloroquine, Carboplatin, Paclitaxel, and Bevacizumab in Recurrent Advanced Non-Small Cell Lung Cancer

Part of paid clinical trials in Hamilton, New Jersey.

Sponsor
University of Medicine and Dentistry of New Jersey
Study ID
NCT00728845
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    Only patients eligible for bevacizumab will receive bevacizumab. Dose is at 15 mg/kg on day 1 of each cycle.
  • carboplatin — DRUG
    Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel
  • hydroxychloroquine — DRUG
    200 mg orally BID (total daily dose of 400 mg)
  • paclitaxel — DRUG
    Dose of 200 mg/m2 IV on day 1 of each cycle

Study Details

RATIONALE: Drugs used in chemotherapy, such as hydroxychloroquine, carboplatin, and paclitaxel and work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving hydroxychloroquine together with carboplatin, paclitaxel and bevacizumab may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of hydroxychloroquine when given together with carboplatin, paclitaxel, and bevacizumab and to see how well they work in treating patients with recurrent advanced non-small cell lung cancer.

Key Dates

First listed
Aug 6, 2008
Start date
Jun 16, 2008
Status verified
Apr 2017
Primary completion
Dec 21, 2010
Completion
Dec 21, 2010

Study Design

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

Arms

  • Experimental: Hydroxychloroquine, Carboplatin, Paclitaxel, Bevacizumab
    Cohort 1: Bevacizumab Eligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min Bevacizumab 15 mg/kg IV over 90 min for PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles
  • Experimental: Hydroxychloroquine, Carboplatin, Paclitaxel
    Cohort 2: Bevacizumab Ineligible Patients All on Day 1 Paclitaxel 200mg/m2 IV over 3 hours Carboplatin AUC= 6 IV over 15-30 min PLUS Hydroxychloroquine 200 mg PO BID Cycles every 3 weeks for 4-6 Cycles

Primary Outcome Measure

Recommended Phase II Dose of Hydroxychloroquine and Carboplatin When Administered With Paclitaxel and Bevacizumab (Phase I) [ Time Frame: Followed for the duration of the phase 1 treatment, an average of 18 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cancer Institute of New Jersey at HamiltonHamiltonNew Jersey08690-
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08903-

Find similar trials in Hamilton, NJ

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Cancer Institute of New Jersey at Hamilton· Hamilton, NJCancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School· New Brunswick, NJ

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