Pemetrexed or Docetaxel With or Without Erlotinib in Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT00660816
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • erlotinib hydrochloride — DRUG
    Given orally once daily on days 2-19.
  • pemetrexed disodium — DRUG
    Given IV over 10 minutes on day 1
  • docetaxel — DRUG
    IV over 60 minutes on day 1.

Study Details

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

Key Dates

First listed
Apr 17, 2008
Start date
Jan 31, 2008
Status verified
Oct 2015
Primary completion
Apr 30, 2013
Completion
Jul 31, 2015

Study Design

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

Arms

  • Active Comparator: Arm I
    Patients receive pemetrexed disodium IV over 10 minutes OR docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive standard chemotherapy with or without erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II
    Patients receive pemetrexed disodium IV over 10 minutes OR docetaxel IV over 60 minutes on day 1 and erlotinib hydrochloride PO once daily on days 2-19. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue to receive standard chemotherapy with or without erlotinib hydrochloride in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival [ Time Frame: 18 months after enrollment of last patient ]

Locations (13)

FacilityCityStateZIPSite coordinators
Wayne State UniversityDetroitMichigan48202-
Columbia PresbyterianNew YorkNew York10032-
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterClevelandOhio44106-5065-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-
Lake/University Ireland Cancer CenterClevelandOhio44060-
MetroHealth Medical CenterClevelandOhio44109-
Southwest General Health CenterClevelandOhio44130-
UHHS Chagrin Highlands Medical CenterClevelandOhio44122-
UHHS Westlake Medical CenterClevelandOhio44145-
Ohio State UniversityColumbusOhio43210-
Riverside Methodist HospitalColumbusOhio43124-
UH-MonarchMayfield HeightsOhio44124-
UH-FirelandsSanduskyOhio44870-

Find similar trials in Detroit, MI

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Wayne State University· Detroit, MIColumbia Presbyterian· New York, NYCase Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center· Cleveland, OHCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OHLake/University Ireland Cancer Center· Cleveland, OHMetroHealth Medical Center· Cleveland, OH

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