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Clinical Trial Record

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Tarceva and Capecitabine for Pancreatic Cancer

2003-10

2004-06

2008-09

32

Study Overview

Tarceva and Capecitabine for Pancreatic Cancer

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

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.

  • Pancreatic Cancer
  • Neoplasm Metastasis
  • DRUG: Capecitabine
  • DRUG: OSI-774
  • 03-070

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2005-07-27  

N/A  

2009-10-30  

2005-07-27  

N/A  

2009-11-02  

2005-07-29  

N/A  

2009-10  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
Primary Outcome MeasuresMeasure DescriptionTime Frame
To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer
Secondary Outcome MeasuresMeasure DescriptionTime Frame
To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer2 years
to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • 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

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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