Randomized Phase II Trial, Comparing Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Plus Erlotinib to Standard of Care Chemotherapy (Pemetrexed or Docetaxel) Alone in EGFR TKI-Responsive Non-Small Cell Lung Cancer
OBJECTIVES:
Primary
- To evaluate whether maintenance erlotinib hydrochloride added to standard of care
(pemetrexed disodium or docetaxel) chemotherapy in patients with erlotinib
hydrochloride-responsive advanced non-small cell lung cancer leads to an improved
progression-free survival as compared to standard of care pemetrexed disodium or
docetaxel alone.
Secondary
- To evaluate the effect of maintenance erlotinib hydrochloride on the response rate to
standard of care (pemetrexed disodium or docetaxel) therapy in patients with erlotinib
hydrochloride-responsive advanced non-small cell lung cancer as compared to standard of
care (pemetrexed disodium or docetaxel) alone.
- To evaluate whether maintenance erlotinib hydrochloride added to standard of care
(pemetrexed disodium or docetaxel) chemotherapy in patients with erlotinib
hydrochloride-responsive advanced non-small cell lung cancer leads to an improved
overall survival as compared to standard of care (pemetrexed disodium or docetaxel)
alone.
- To evaluate the effect of maintenance erlotinib hydrochloride on the disease
stabilization (complete response [CR] + partial response [PR] + stable disease [SD])
rate to standard of care (pemetrexed disodium or docetaxel) therapy in patients with
erlotinib hydrochloride-responsive advanced non-small cell lung cancer as compared to
standard of care (pemetrexed disodium or docetaxel) alone.
- To evaluate the utility of early positron emission tomography (PET) scanning (baseline
versus 1 cycle of protocol therapy) on overall disease assessment and prediction of
treatment responsiveness.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to
lifetime smoking status (never vs ever) and ECOG performance status (0-1 vs ≥ 2). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: (standard of care alone): Patients receive pemetrexed disodium intravenously
(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.
- Arm II: (standard of care plus erlotinib): Patients receive pemetrexed disodium IV over
10 minutes OR docetaxel IV over 60 minutes on day 1 and erlotinib hydrochloride orally
(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.
After completion of study treatment, patients are followed up every 8 weeks.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
From the date of randomization to the date of disease progression or the date of death, whichever occurs first and censored at the date of last followed for those survivors without disease progression.
6 months after enrollment of last patient
No
Afshin Dowlati, MD
Principal Investigator
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
CASE2507
NCT00660816
January 2008
Name | Location |
---|---|
Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
UH-Monarch | Mayfield Heights, Ohio 44124 |
Wayne State University | Detroit, Michigan 48202 |
Ohio State University | Columbus, Ohio 43210 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Southwest General Health Center | Middleburgh Heights, Ohio 44130 |
UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
UH-Firelands | Sandusky, Ohio 44870 |
Columbia Presbyterian | New York City, New York 10032 |