Pemetrexed Disodium, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT00438204
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — BIOLOGICAL
    Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days
  • gemcitabine hydrochloride — DRUG
    Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days
  • pemetrexed disodium — DRUG
    Pemetrexed disodium 400 mg/m2 intravenously over 10 minutes every 14 days.

Study Details

RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, 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 pemetrexed disodium and gemcitabine together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving pemetrexed disodium and gemcitabine together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Key Dates

First listed
Feb 22, 2007
Start date
May 31, 2006
Status verified
Mar 2021
Primary completion
Mar 31, 2013
Completion
Jun 30, 2016

Study Design

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

Arms

  • Experimental: Bevacizumab, gemcitabine hydrochloride
    Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed disodium every 14 days Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Up to 12 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-0942-
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-1379-

Find similar trials in Ann Arbor, MI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Michigan Comprehensive Cancer Center· Ann Arbor, MIBarbara Ann Karmanos Cancer Institute· Detroit, MI

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