Back to resultsErlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
Primary Purpose
Advanced Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
erlotinib
gemcitabine
nab-paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Pancreatic Cancer focused on measuring erlotinib, nab-paclitaxel, gemcitabine, Adenocarcinoma, Advanced Pancreatic Cancer, Phase 1b
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Desert Comprehensive Cancer Center
- University of Colorado Cancer Center
- University of North Carolina
- Fox Chase Cancer Center
- Vanderbilt Ingram Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
erlotinib, gemcitabine, nab-paclitaxel
Arm Description
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.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose
Secondary Outcome Measures
Safety of drug combination assessed through dose limiting toxicities (DLTs)
Safety of drug combination assessed through Adverse Events (AEs)
Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)
Objective Response Rate
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01010945
Brief Title
Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
Official Title
A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 3, 2010 (Actual)
Primary Completion Date
January 25, 2012 (Actual)
Study Completion Date
January 25, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OSI Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Cancer
Keywords
erlotinib, nab-paclitaxel, gemcitabine, Adenocarcinoma, Advanced Pancreatic Cancer, Phase 1b
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
erlotinib, gemcitabine, nab-paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
erlotinib
Other Intervention Name(s)
Tarceva, OSI-774
Intervention Description
administered orally
Intervention Type
Drug
Intervention Name(s)
gemcitabine
Intervention Description
administered intravenously
Intervention Type
Drug
Intervention Name(s)
nab-paclitaxel
Intervention Description
administered intravenously
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose
Time Frame
Monthly (to a maximum of 12 months)
Secondary Outcome Measure Information:
Title
Safety of drug combination assessed through dose limiting toxicities (DLTs)
Time Frame
1 month
Title
Safety of drug combination assessed through Adverse Events (AEs)
Time Frame
Monthly (to a maximum of 12 months)
Title
Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)
Time Frame
Days 29 (Cycle 2, Day 1) and 30
Title
Objective Response Rate
Description
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)
Title
Progression Free Survival (PFS)
Description
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)
Title
Overall Survival
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Desert Comprehensive Cancer Center
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
University of Colorado Cancer Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Vanderbilt Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=330
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer
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