Pemetrexed Disodium With or Without Erlotinib Hydrochloride in Treating Patients With Stage IIIB-IV or Recurrent Non-Small Cell Lung Cancer

Part of paid clinical trials in Sacramento, California.

Sponsor
Albert Einstein College of Medicine
Study ID
NCT00950365
Phase
PHASE2
Status
Completed

Conditions

  • Bronchioloalveolar Carcinoma
  • Large Cell Lung Carcinoma
  • Lung Adenocarcinoma
  • Recurrent Non-Small Cell Lung Carcinoma
  • Stage IIIB Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pemetrexed Disodium — DRUG
    Given IV

Study Details

This randomized phase II trial studies how well pemetrexed disodium with or without erlotinib hydrochloride works in treating patients with stage IIIB-IV or recurrent non-small cell lung cancer. Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective with or without erlotinib hydrochloride in treating non-small cell lung cancer.

Key Dates

First listed
Jul 31, 2009
Start date
Apr 30, 2006
Status verified
Aug 2020
Primary completion
Nov 17, 2017
Completion
Nov 17, 2017

Study Design

Enrollment
79 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (pemetrexed)
    Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm B (pemetrexed disodium, erlotinib hydrochloride)
    Patients receive pemetrexed disodium IV as in Arm A and erlotinib hydrochloride PO QD on days 2-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

PFS (Progression Free Survival) [ Time Frame: Time from randomization until documented tumor progression or death from any cause, assessed up to 12 months ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
University of Massachusetts Memorial Health CareWorcesterMassachusetts01605-
Albert Einstein College of MedicineThe BronxNew York10461-
Bronx River Medical Associates PCThe BronxNew York10467-
Eastchester Center for Cancer CareThe BronxNew York10469-

Find similar trials in Sacramento, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of California Davis Comprehensive Cancer Center· Sacramento, CAUniversity of Massachusetts Memorial Health Care· Worcester, MAAlbert Einstein College of Medicine· The Bronx, NYBronx River Medical Associates PC· The Bronx, NYEastchester Center for Cancer Care· The Bronx, NY

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