Phase I Study of LBH589 & Erlotinib for Advanced Aerodigestive Tract Cancers
The purpose of the study is to:
- Find out if Erlotinib and LBH589 can be safely given together in patients with advanced non-small cell lung cancer (NSCLC) or Head and Neck (H&N) Cancer.
- Learn more about the side effects of these two drugs when combined together.
- Learn how these two drugs work in cancer cells when they are combined.
- Learn how this combination affects the ways in which they are absorbed by the body and eliminated.
- Find the highest doses of Erlotinib and LBH589 that can be safely given without causing serious side effects.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of LBH589 in Combination With Erlotinib for Advanced Aerodigestive Tract Cancers (CLBH5889CUS11T)|
- Maximum Tolerated Dose (MTD) [ Time Frame: 4 Months ] [ Designated as safety issue: Yes ]Determine safety and tolerability of erlotinib and LBH589B and establish a recommended phase II expansion dosing of LBH589B and erlotinib in patients with advanced aerodigestive tract cancers.
- Number of Participants With Progression Free Survival (PFS) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]Evaluate safety of erlotinib/LBH589B, pharmacokinetic drug levels of Erlotinib, full profile of single agent vs. combination; biomarkers of acetylation; objective response rate; 6-mo. progression free survival rate; time-to-event variables.
- Duration of Stable Disease (SD) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Participants' duration of stable disease up to 1 year.
- Number of Participants With Overall Survival (OS) [ Time Frame: 1 Year ] [ Designated as safety issue: No ]Overall survival time up to 1 year.
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: A - Dose Escalation
12-24 patients will be enrolled in the phase I component. 10 additional patients with NSCLC and 10 additional patients with Head and Neck Cancer (HNCa) will be treated at the Phase I expansion dose. One treatment cycle will be defined as a 21 day course of erlotinib with a total of 4 doses of LBH589 given biweekly on Tuesday and Friday for 1 week off and 2 weeks on (Days 8, 11, 15, and 18).
During the study, LBH589 will be administered orally as biweekly dose of 20-40 mg (20 mg and 5 mg capsules are available) on Mondays and Thursday, one week off, then two weeks on.
Cycle # 1 week 2 dosing will be the exception. The LBH589 for cycle 1 week 2 will be given on day 9 and 12 (Tuesday and Friday) due to the pharmacokinetic (PK) sampling for that week.
Patients may continue treatment with oral LBH589 until they experience unacceptable toxicity that precludes further treatment, disease progression, and/or at the discretion of the investigator.
Other Names:Drug: erlotinib
Erlotinib will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent erlotinib, 100-150 mg/day (dose will depend upon which dose level that patient is enrolled in. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration.
Patients will be asked to remain on the study for a minimum of 3 months unless the study doctor decides the patient should be taken off the study or the patient withdraws from the study. Each cycle of treatment is 21 days in length and there is a 30 day follow-up after the patient receives their last dose of study drug. Scans will be repeated to see how their cancer is doing after two cycles of treatment. These scans wil be repeated every 2 cycles for the first 6 cycles and then every 3 cycles for as long as the patient remains on the study. The patient may continue on therapy as long as they are responding or have stable disease.
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Jhanelle Gray, M.D.||H. Lee Moffitt Cancer Center and Research Institute|