Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

Advanced Pancreatic Cancer Clinical Trial

Official title:

A Phase Ib Study of Erlotinib in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Previously Untreated Advanced Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010945
• Other study ID #: OSI-774-108
• Secondary ID: 09PAN01
• Status: Completed
• Phase: Phase 1
• Start date: February 3, 2010
• Est. completion date: January 25, 2012

Study information

• Verified date: June 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 25, 2012
• Est. primary completion date: January 25, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• erlotinib
administered orally
• gemcitabine
administered intravenously
• nab-paclitaxel
administered intravenously

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Vanderbilt Ingram Cancer Center	Nashville	Tennessee
United States	Desert Comprehensive Cancer Center	Palm Springs	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
OSI Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose		Monthly (to a maximum of 12 months)
Secondary	Safety of drug combination assessed through dose limiting toxicities (DLTs)		1 month
Secondary	Safety of drug combination assessed through Adverse Events (AEs)		Monthly (to a maximum of 12 months)
Secondary	Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)		Days 29 (Cycle 2, Day 1) and 30
Secondary	Objective Response Rate	Response will be based on the RECIST v1.1 criteria. Patients with partial and complete response will be classified as "responders".	Monthly (to a maximum of 12 months)
Secondary	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.	Monthly (to a maximum of 12 months)
Secondary	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.	Monthly (to a maximum of 12 months)

External Links

•   Link to results on Astellas Clinical Study Results website