4-HPR and FTI in Head and Neck Squamous Cell Carcinoma (HNSCC)
The primary objective of this study is to estimate the modulation of intermediate biological endpoints of the combination of 4-HPR and SCH66336, a farnesyl transferase inhibitor (FTI), across 4 randomly assigned dose levels in patients with locally advanced or recurrent head and neck cancer. We will also assess the activity, safety, tolerability and side effects of 4-HPR/SCH66336 and hope to establish a phase II regimen.
|Study Design:||Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IB Randomized Translational Study of Fenretinide (4-HPR) in Combination With SCH66336, a Farnesyl Transferase Inhibitor, in Patients With Advanced or Recurrent Head and Neck Cancer|
- Maximum Tolerated Dose (MTD) [ Time Frame: 21 day courses ] [ Designated as safety issue: Yes ]MTD derived from lack of dose limiting toxicities (DLT) in 4 differing dose levels.
|Study Start Date:||January 2005|
|Study Completion Date:||November 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
Experimental: 4-HPR + FTI
SCH66336 daily for 21 days each cycle and with 4-HPR daily on days 1-7 only. On day 1 of cycle 1, 4-HPR only beginning SCH66336 on day 2 of cycle 1.
Drug: Fenretinide (4-HPR)
Oral 100 mg capsules in two divided doses at least 8 hours apart for 7 days each cycle.Drug: SCH66336
Oral capsules with 50 mg, 75 mg, or 100 mg formulation in two divided doses at least 8 hours apart for 21 days each cycle.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Edward S Kim, MD||M.D. Anderson Cancer Center|