This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.
This is a single-arm, phase 1b study to determine the maximum tolerated dose (MTD) of the combination of erlotinib (daily), gemcitabine (weekly), nab-paclitaxel (weekly) in patients with advanced pancreatic cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
19
administered orally
administered intravenously
administered intravenously
Desert Comprehensive Cancer Center
Palm Springs, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Maximum Tolerated Dose
Time frame: Monthly (to a maximum of 12 months)
Safety of drug combination assessed through dose limiting toxicities (DLTs)
Time frame: 1 month
Safety of drug combination assessed through Adverse Events (AEs)
Time frame: Monthly (to a maximum of 12 months)
Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)
Time frame: Days 29 (Cycle 2, Day 1) and 30
Objective Response Rate
Response will be based on the RECIST v1.1 criteria. Patients with partial and complete response will be classified as "responders".
Time frame: Monthly (to a maximum of 12 months)
Progression Free Survival (PFS)
PFS will be calculated as the time from start of treatment until disease progression or death; patients who are still alive and free of progression at their last follow-up will be censored at that time.
Time frame: Monthly (to a maximum of 12 months)
Overall Survival
Survival will be calculated as the time from start of treatment until death of any cause, patients who are still alive at their last follow-up will be censored at that time.
Time frame: Monthly (to a maximum of 12 months)
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Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States