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Tarceva and Capecitabine for Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00125021
Recruitment Status : Completed
First Posted : July 29, 2005
Last Update Posted : November 2, 2009
Information provided by:

Study Description
Brief Summary:
This phase II trial is designed to investigate the effectiveness of Tarceva (OSI-774) combined with capecitabine in treating patients with metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Neoplasm Metastasis Drug: Capecitabine Drug: OSI-774 Phase 2

Detailed Description:
Patients will be treated once daily with Tarceva, twice daily with capecitabine for 14 consecutive days, followed by 7 days off of capecitabine (a cycle is 21 days). At week 1 of each cycle a physical exam and blood work will be performed. Reassessment of tumor size will be conducted at 6 weeks (2 cycles), 12 weeks (4 cycles) and then every 9 weeks thereafter. Patients will remain on treatment until one of the following occur: disease progression, illness that prevents further treatment or unacceptable adverse events.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer
Study Start Date : October 2003
Primary Completion Date : June 2004
Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Capecitabine
    Given twice a day for 14 days followed by 7 days of no capecitabine (1 cycle is 21 days).
    Drug: OSI-774
    Given once daily
    Other Name: Tarceva

Outcome Measures

Primary Outcome Measures :
  1. To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer

Secondary Outcome Measures :
  1. To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer [ Time Frame: 2 years ]
  2. to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774

Eligibility Criteria

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

Inclusion Criteria:

  • Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors)
  • Only patients with measurable disease
  • ECOG performance status < or equal to 1
  • Life expectancy >12 weeks
  • Signed informed consent
  • Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease.
  • >4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities
  • >4 weeks must have elapsed from the participation in any investigational drug study
  • Laboratory values:

    • ANC > 1500/mm3;
    • Hemoglobin > 9.0 gm/dl;
    • Platelets > 100,000/mm3;
    • SGOT <2.5 X upper limit of normal; or <5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase < 2.5 X upper limit of normal; or < 5 X upper limit of normal if evidence of liver metastases; Total bilirubin < 1.5 X upper limit of normal; Creatinine clearance > 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection).

Exclusion Criteria:

  • Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors
  • More than one prior chemotherapy treatment regimen for metastatic disease
  • Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months).
  • Major surgery within 4 weeks of the start of study treatment, without complete recovery.
  • Evidence of CNS metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders
  • Uncontrolled serious medical or psychiatric illness
  • Women must not be pregnant or lactating
  • Concurrent radiation therapy
  • Other active malignancy
  • Inability to swallow tablets
  • Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome
  • Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00125021

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Genentech, Inc.
Roche Global Development
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
More Information

Responsible Party: Matthew Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00125021     History of Changes
Other Study ID Numbers: 03-070
First Posted: July 29, 2005    Key Record Dates
Last Update Posted: November 2, 2009
Last Verified: October 2009

Keywords provided by Dana-Farber Cancer Institute:
Second Line Therapy
Gemcitabine Refractory
Pancreatic Cancer
Metastatic Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors