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Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

This study has been completed.
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
University of California, Davis Identifier:
First received: December 17, 2008
Last updated: March 20, 2017
Last verified: March 2017

RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with erlotinib may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine together with erlotinib works in treating patients with metastatic or recurrent pancreatic cancer.

Condition Intervention Phase
Pancreatic Cancer
Drug: Erlotinib
Drug: gemcitabine
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer

Resource links provided by NLM:

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: Up to 36 months ]
    Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Secondary Outcome Measures:
  • Response Rate [ Time Frame: Up to 36 months ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  • Overall Survival [ Time Frame: Up to 36 months ]
    Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up.

Enrollment: 30
Study Start Date: April 2009
Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine and Erlotinib
The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.
Drug: Erlotinib
Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.
Other Name: Tarceva
Drug: gemcitabine
The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.
Other Name: Gemzar

Detailed Description:

OUTLINE: This is a multicenter study.

Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15 and oral erlotinib hydrochloride on days 2-5, 9-12, and 16-26. Treatment repeats every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

Archived tumor tissue samples are analyzed for the expression of EGFR, HER3, HER2, downstream signaling molecules, and other molecular markers by immunohistochemistry and RT-PCR. The presence of aberrant gene copy numbers (amplification and polysomy) for EGFR, HER3, and HER2 are determined by FISH. Blood samples are collected at baseline and periodically during study for polymorphism analysis and correlative molecular analysis of surrogate endpoint biomarkers.

After completion of study therapy, patients are followed every 3 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed locally advanced, metastatic or recurrent pancreatic carcinoma
  • Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
  • No prior chemotherapy for metastatic or recurrent disease is allowed. Prior adjuvant chemotherapy is allowed provided that patients did not receive gemcitabine and the chemotherapy was completed > six months prior to initiation of study therapy. Prior erlotinib therapy is not allowed
  • Available tumor specimen that was obtained at the time of diagnosis and/or prior to study entry is highly encouraged
  • Age ≥ 18 years
  • Life expectancy greater than 3 months
  • Zubrod performance status ≤ 2
  • Patients must have normal organ and marrow function as defined below:
  • leukocytes ≥ 3,000/μL
  • absolute neutrophil count ≥ 1,500/ μL
  • platelets ≥ 100,000/ μL
  • total bilirubin ≤ 1.5 X institutional upper limit of normal
  • AST(SGOT)/ALT(SGPT) ≤ 3 X institutional upper limit of normal, unless the liver is involved with tumor, in which case the AST/ALT must be ≤ 5 X institutional upper limit of normal
  • creatinine clearance ≥ 50 mL/min/1.73 m2, as measured by 24hour collection OR
  • creatinine ≤ 1.5 X institutional upper limit of normal
  • The effects of erlotinib and gemcitabine on the developing human fetus at the recommended therapeutic doses are unknown. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients may not be receiving any other investigational agents.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to erlotinib or gemcitabine.
  • Secondary primary malignancy. Concurrent or history of another malignancy < 5 years.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because erlotinib and gemcitabine have the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued if the mother is treated with study drugs.
  • Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00810719

United States, California
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Cancer Institute (NCI)
Genentech, Inc.
Principal Investigator: Primo N. Lara, MD University of California, Davis
  More Information

Responsible Party: University of California, Davis Identifier: NCT00810719     History of Changes
Other Study ID Numbers: UCDCC#211
P30CA093373 ( US NIH Grant/Contract Award Number )
OSI 4132s ( Other Identifier: Genentech )
Study First Received: December 17, 2008
Results First Received: January 13, 2017
Last Updated: March 20, 2017

Keywords provided by University of California, Davis:
recurrent pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors processed this record on May 24, 2017