Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

Sponsor

OSI Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01010945

Collaborator

(none)

Enrollment

Locations

Arm

23.7

Actual Duration (Months)

3.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Pancreatic Cancer	Drug: erlotinib Drug: gemcitabine Drug: nab-paclitaxel	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 3, 2010

Actual Primary Completion Date :

Jan 25, 2012

Actual Study Completion Date :

Jan 25, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: erlotinib, gemcitabine, 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.	Drug: erlotinib administered orally Other Names: Tarceva OSI-774 Drug: gemcitabine administered intravenously Drug: nab-paclitaxel administered intravenously

Arm

Intervention/Treatment

Experimental: erlotinib, gemcitabine, 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.

Drug: erlotinib

administered orally

Other Names:

Tarceva

OSI-774

Drug: gemcitabine

administered intravenously

Drug: nab-paclitaxel

administered intravenously

Outcome Measures

Primary Outcome Measures

Maximum Tolerated Dose [Monthly (to a maximum of 12 months)]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Desert Comprehensive Cancer Center	Palm Springs	California	United States	92262
2	University of Colorado Cancer Center	Aurora	Colorado	United States	80045
3	University of North Carolina	Chapel Hill	North Carolina	United States	27514
4	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
5	Vanderbilt Ingram Cancer Center	Nashville	Tennessee	United States	37232