Erlotinib, Gemcitabine and Nab-Paclitaxel in Advanced Pancreatic Cancer

June 5, 2019 updated by: OSI Pharmaceuticals

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

This is a phase 1b study to evaluate the combination of gemcitabine and Tarceva (erlotinib) and nab-paclitaxel in patients with advanced pancreatic cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palm Springs, California, United States, 92262
        • Desert Comprehensive Cancer Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Cancer Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • University of North Carolina
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum Tolerated Dose
Time Frame: Monthly (to a maximum of 12 months)
Monthly (to a maximum of 12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of drug combination assessed through dose limiting toxicities (DLTs)
Time Frame: 1 month
1 month
Safety of drug combination assessed through Adverse Events (AEs)
Time Frame: Monthly (to a maximum of 12 months)
Monthly (to a maximum of 12 months)
Evaluate erlotinib Pharmacokinetic (PK) trough concentrations (C24h)
Time Frame: Days 29 (Cycle 2, Day 1) and 30
Days 29 (Cycle 2, Day 1) and 30
Objective Response Rate
Time Frame: 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".
Monthly (to a maximum of 12 months)
Progression Free Survival (PFS)
Time Frame: 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.
Monthly (to a maximum of 12 months)
Overall Survival
Time Frame: 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.
Monthly (to a maximum of 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OSI Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 3, 2010

Primary Completion (ACTUAL)

January 25, 2012

Study Completion (ACTUAL)

January 25, 2012

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (ESTIMATE)

November 10, 2009

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSI-774-108
  • 09PAN01 (OTHER: Criterium Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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."

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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