Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer
2 other identifiers
interventional
19
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2010
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 6, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedStudy Start
First participant enrolled
February 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 25, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2012
CompletedNovember 21, 2024
November 1, 2024
2 years
November 6, 2009
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose
Monthly (to a maximum of 12 months)
Secondary Outcomes (6)
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)
Progression Free Survival (PFS)
Monthly (to a maximum of 12 months)
- +1 more secondary outcomes
Study Arms (1)
erlotinib, gemcitabine, nab-paclitaxel
EXPERIMENTALPatients 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.
Interventions
administered orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Desert Comprehensive Cancer Center
Palm Springs, California, 92262, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Astellas Pharma Global Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2009
First Posted
November 10, 2009
Study Start
February 3, 2010
Primary Completion
January 25, 2012
Study Completion
January 25, 2012
Last Updated
November 21, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.