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Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: December 17, 2008   Last Updated: July 7, 2009   History of Changes
Sponsors and Collaborators: University of California, Davis
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00810719
  Purpose

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 hydrochloride
Drug: gemcitabine hydrochloride
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: polymorphism analysis
Genetic: protein expression analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: immunohistochemistry staining method
Other: laboratory biomarker analysis
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label
Official Title: Phase II Study of Gemcitabine and Intermittent Erlotinib in Advanced Pancreatic Cancer (OSI 4132s)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate (partial response or complete response) and duration of response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: April 2009
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the progression-free survival of patients with metastatic or recurrent pancreatic cancer treated with gemcitabine hydrochloride and intermittent erlotinib hydrochloride.

Secondary

  • To determine the response rate in patients treated with this regimen.
  • To determine the overall survival of patients treated with this regimen.
  • To investigate potential predictors of response to treatment by performing correlative laboratory studies using blood and tissue samples from these patients.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed pancreatic cancer

    • Metastatic or recurrent disease
  • Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
  • Must have tumor specimen (paraffin embedded or fresh frozen) available
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Life expectancy > 3 months
  • WBC ≥ 3,000/mm^3
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST/ALT ≤ 3 times ULN (≤ 5 times ULN for tumor involvement of the liver)
  • Creatinine clearance ≥ 50 mL/min OR creatinine ≤ 1.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to erlotinib hydrochloride or gemcitabine hydrochloride
  • No other malignancy within the past 5 years, except carcinoma in situ, adequately treated nonmelanoma skin cancer, or other malignancy treated ≥ 5 years ago with no evidence of recurrence
  • No concurrent uncontrolled illness including, but not limited to, the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Uncontrolled hypertension
    • Psychiatric illness or social situation that would limit compliance with study requirements
  • No HIV positivity

PRIOR CONCURRENT THERAPY:

  • More than 6 months since prior adjuvant chemotherapy
  • No prior gemcitabine hydrochloride or erlotinib hydrochloride
  • No prior chemotherapy for metastatic or recurrent disease
  • No other concurrent antineoplastic or antitumor therapy, including chemotherapy, radiotherapy, immunotherapy, or hormonal anticancer therapy
  • No other concurrent investigational agents
  • No concurrent combination antiretroviral therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810719

Locations
United States, California
University of California Davis Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Clinical Trials Office - University of California Davis Cancer     916-734-3089        
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Primo N. Lara, MD University of California, Davis
  More Information

Additional Information:
No publications provided

Responsible Party: University of California Davis Cancer Center ( Primo N. Lara )
Study ID Numbers: CDR0000629891, UCD-211, GENENTECH-UCD-211, IRB#200816732-1
Study First Received: December 17, 2008
Last Updated: July 7, 2009
ClinicalTrials.gov Identifier: NCT00810719     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent pancreatic cancer
stage IV pancreatic cancer

Study placed in the following topic categories:
Erlotinib
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Immunologic Factors
Pancreatic Neoplasms
Endocrine System Diseases
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Recurrence
Digestive System Diseases
Radiation-Sensitizing Agents
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Erlotinib
Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors
Protein Kinase Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on September 03, 2009