Gemcitabine, Capecitabine, and Erlotinib in Treating Patients With Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00885066
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
Centre Antoine Lacassagne

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, 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.

PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given together with capecitabine and erlotinib in treating patients with advanced pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: capecitabine Drug: erlotinib hydrochloride Drug: gemcitabine hydrochloride Phase 1

Detailed Description:



  • Determine the maximum-tolerated dose of the combination of gemcitabine hydrochloride, capecitabine, and erlotinib hydrochloride in patients with advanced pancreatic cancer.


  • Analyze the limiting toxicities according to CTC.
  • Analyze the toxicity according to CTC.
  • Determine the recommended dose.
  • Determine the pharmacokinetic dosages of the three drugs.
  • Analyze interactions between the drugs.

OUTLINE: This is a multicenter study.

Patients receive one course of chemotherapy comprising gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15, oral capecitabine twice daily on days 1-21, and oral erlotinib hydrochloride once daily on days 1-28.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Gemcitabine, Capecitabine, and Erlotinib Together in Advanced Pancreatic Cancers
Study Start Date : May 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: gemcitabine, capecitabine, erlotinib Drug: capecitabine
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride

Primary Outcome Measures :
  1. Clinical or laboratory toxicities as assessed by CTC [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed adenocarcinoma of the pancreas

    • Advanced disease
  • No standard curative therapy available
  • Must have received prior first-line chemotherapy
  • No brain metastasis


  • WHO performance status 0-2
  • Life expectancy ≥ 8 weeks
  • ANC ≥ 1.5 x 10^9/ L
  • Platelet count ≥ 130 x 10^9/ L
  • Hemoglobin ≥ 10 g/dL
  • Liver transaminases ≤ 1.5 times upper limit of normal (ULN) (≤ 5 times ULN in the presence of liver metastases)
  • Bilirubin ≤ 1.5 times ULN
  • Creatinine ≤ 130 mmol/L OR creatinine clearance > 30 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No intolerance or hypersensitivity to any of the drugs being tested
  • No history of interstitial lung disease
  • No history of severe cardiac disease
  • No serious uncontrolled infection
  • No rare hereditary disorders, i.e., galactosemia, lactase deficiency, or malabsorption of glucose or galactose syndrome
  • Must not be deprived of liberty or under guardianship
  • Must not be on probation


  • See Disease Characteristics
  • No prior erlotinib hydrochloride
  • No concurrent potent inducers or inhibitors of cytochrome P450 or CYP3A4
  • More than 14 days since participation in another clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00885066

Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Principal Investigator: Eric Francois Centre Antoine Lacassagne

Responsible Party: Centre Antoine Lacassagne Identifier: NCT00885066     History of Changes
Other Study ID Numbers: CDR0000633338
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Keywords provided by Centre Antoine Lacassagne:
stage III pancreatic cancer
stage IV pancreatic cancer
adenocarcinoma of the pancreas
recurrent 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