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

Phase 1
18 Years
Not Enrolling
Advanced Pancreatic Cancer

Thank you

Trial Information

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

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.

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 creatine <= 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose

Outcome Time Frame:

Monthly (to a maximum of 12 months)

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

January 2012

Related Keywords:

  • Advanced Pancreatic Cancer
  • Advanced Pancreatic Cancer
  • erlotinib
  • gemcitabine
  • nab-paclitaxel
  • Adenocarcinoma
  • Phase 1b
  • Pancreatic Neoplasms



University of Colorado Cancer Center Denver, Colorado  80262
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
University of North Carolina Chapel Hill, North Carolina  27599
Vanderbilt Ingram Cancer Center Nashville, Tennessee  37232
Desert Comprehensive Cancer Center Palm Springs, California  92262