Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Relapsed Non-Small-Cell Lung Cancer Refractory Non-Small-Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
The reason for this study will be to find the safest maximum tolerated dose of oral vorinostat in combination with erlotinib \[Tarceva (TM)\] that can be given to patients with lung cancer who have relapsed or failed other therapy for the disease. Once the safest maximum tolerated dose of vorinostat is determined, patients enrolled in the clinical trial will continue vorinostat and erlotinib for up to 8 months. Safety and effectiveness will also be evaluated.

Detailed description:

Arms:
arm 1: Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion arm 2: Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. arm 3: Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study. arm 4: Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.

Interventions: intervention 1: Vorinostat intervention 2: Vorinostat intervention 3: Vorinostat intervention 4: Vorinostat intervention 5: erlotinib
Intervention descriptions: intervention 1: Vorinostat 200 mg twice a day for 3 days a week. intervention 2: Vorinostat 300 mg once a day for 3 days a week. intervention 3: Vorinostat 300 mg twice a day for 3 days a week. intervention 4: Vorinostat 400 mg once a day for 21 out of 28 days. intervention 5: erlotinib 150 mg once a day.

Protocol document: