Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
- Conditions
- Advanced Pancreatic Cancer
- Interventions
- Registration Number
- NCT01010945
- Lead Sponsor
- OSI Pharmaceuticals
- Brief Summary
This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
-
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1
-
Predicted life expectancy of >= 12 weeks
-
Previous surgery
-
Histologically or cytologically confirmed, measurable, locally advanced, unresectable or metastatic pancreatic adenocarcinoma
-
No prior therapy for pancreatic cancer
-
Adequate organ and marrow function
- Absolute neutrophil count >= 1.5 x 10^9/L
- Platelets >= 100 x 10^9/L
- Total bilirubin <= institutional upper limits of normal
- AST (SGOT)/ALT(SGPT) <= 2 x institutional upper limits of normal
- Serum creatinine <= 1.5 x upper limits of normal
-
Negative pregnancy test
-
Informed consent
-
Patient must agree not to smoke while on study
- Significant history of cardiac disease unless the disease is well controlled
- Active or uncontrolled infections or serious illness or medical conditions that could interfere with the patient's ongoing participation in study
- History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent
- History of smoking within the previous 14 days before enrollment or positive cotinine test at baseline
- Pregnant or breast-feeding females
- Symptomatic brain metastases that are not stable, that require steroids, that are potentially life-threatening, or that have required radiation within the last 14 days
- History of allergic reactions attributed to compounds of similar chemical or biological composition to the study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description erlotinib, gemcitabine, nab-paclitaxel nab-paclitaxel Patients 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. erlotinib, gemcitabine, nab-paclitaxel erlotinib Patients 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. erlotinib, gemcitabine, nab-paclitaxel gemcitabine Patients 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 Measures
Name Time Method Maximum Tolerated Dose Monthly (to a maximum of 12 months)
- Secondary Outcome Measures
Name Time Method Safety of drug combination assessed through dose limiting toxicities (DLTs) 1 month Safety of drug combination assessed through Adverse Events (AEs) Monthly (to a maximum of 12 months) Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h) Days 29 (Cycle 2, Day 1) and 30 Objective Response Rate Monthly (to a maximum of 12 months) Response will be based on the RECIST v1.1 criteria. Patients with partial and complete response will be classified as "responders".
Progression Free Survival (PFS) Monthly (to a maximum of 12 months) 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.
Overall Survival Monthly (to a maximum of 12 months) 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.
Trial Locations
- Locations (5)
University of Colorado Cancer Center
🇺🇸Aurora, Colorado, United States
Desert Comprehensive Cancer Center
🇺🇸Palm Springs, California, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States