A Phase I/II Clinical Trial of Vorinostat in Combination With Erlotinib for Patients With Relapsed/Refractory Non-Small-Cell Lung Cancer (0683-025)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT00251589
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    Vorinostat 200 mg twice a day for 3 days a week.
  • Vorinostat — DRUG
    Vorinostat 300 mg once a day for 3 days a week.
  • Vorinostat — DRUG
    Vorinostat 300 mg twice a day for 3 days a week.
  • Vorinostat — DRUG
    Vorinostat 400 mg once a day for 21 out of 28 days.
  • erlotinib — DRUG
    erlotinib 150 mg once a day.

Study Details

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.

Key Dates

Start date
Jan 31, 2006
Status verified
Feb 2015
Primary completion
Oct 31, 2007
Completion
Oct 31, 2007

Study Design

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

Arms

  • Experimental: Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
    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
  • Experimental: Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
    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.
  • Experimental: Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk
    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.
  • Experimental: Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk
    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.

Primary Outcome Measure

Dose Limiting Toxicity (DLT) Occurring in Cycle 1 of the Phase I Portion of the Study [ Time Frame: Day 1 to 28 in the Phase I portion of the study ]

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