Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers

Part of paid clinical trials in Asheville, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT01344824
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab — BIOLOGICAL
    15 mg/kg once per 21 day cycle (up to 4 cycles).
  • carboplatin — DRUG
    Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
  • erlotinib hydrochloride — DRUG
    150mg, daily for 21 day cycle (up to 4 cycles)
  • pemetrexed disodium — DRUG
    500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

Study Details

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 non-small cell lung cancer by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer who are light or never smokers.

Key Dates

First listed
Apr 29, 2011
Start date
Mar 31, 2010
Status verified
Jun 2017
Primary completion
May 24, 2016
Completion
Jul 20, 2016

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Single Arm Trial
    Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

Primary Outcome Measure

Progression-free Survival [ Time Frame: 1400 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Mission HospitalAshevilleNorth Carolina28801-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-
CCHC New Bern Cancer CareNew BernNorth Carolina28562-
University of Pittsburgh Medical CenterPittsburghPennsylvania15232-

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