Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
Part of paid clinical trials in Palm Springs, California.
- Sponsor
- OSI Pharmaceuticals
- Study ID
- NCT01010945
- Phase
- PHASE1
- Status
- Completed
Conditions
- Advanced Pancreatic Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- erlotinib — DRUGadministered orally
- gemcitabine — DRUGadministered intravenously
- nab-paclitaxel — DRUGadministered intravenously
Study Details
This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.
Key Dates
- First listed
- Nov 10, 2009
- Start date
- Feb 3, 2010
- Status verified
- Nov 2024
- Primary completion
- Jan 25, 2012
- Completion
- Jan 25, 2012
Study Design
- Enrollment
- 19 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: erlotinib, gemcitabine, nab-paclitaxelPatients receive the following treatment in 28-day cycles: 1) erlotinib: orally once daily from days 1 through 28 continuous dosing; 2) gemcitabine (following nab-paclitaxel): intravenously over 30 minutes on days 1, 8 and 15 every 28 days; and 3) nab-paclitaxel: intravenously over 30 minutes on days 1, 8 and 15 every 28 days.
Primary Outcome Measure
Maximum Tolerated Dose [ Time Frame: Monthly (to a maximum of 12 months) ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Desert Comprehensive Cancer Center | Palm Springs | California | 92262 | - |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | - |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | - |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | - |
| Vanderbilt Ingram Cancer Center | Nashville | Tennessee | 37232 | - |