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Tarceva and Capecitabine for Pancreatic Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Dana-Farber Cancer Institute
Genentech
Roche Global Development
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00125021
  Purpose

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 Intervention Phase
Pancreatic Cancer
Neoplasm Metastasis
Drug: Capecitabine
Drug: OSI-774
Phase II

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Capecitabine Erlotinib Erlotinib hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Study of OSI-774 (Tarceva) in Combination With Capecitabine in Previously Treated Patients With Metastatic Pancreatic Cancer

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To assess the response rate associated with capecitabine and OSI-774 in patients with advanced pancreatic cancer [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the side effects of capecitabine and OSI-774 in patients with advanced pancreatic cancer [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • to estimate the time to progression and overall survival of patients with advanced pancreatic cancer treated with capecitabine and OSI-774 [ Time Frame: TBD ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: October 2003
Estimated Study Completion Date: June 2008
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00125021

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

Responsible Party: Dana-Farber Cancer Institute ( Matthew Kulke, MD )
Study ID Numbers: 03-070
Study First Received: July 27, 2005
Last Updated: December 20, 2007
ClinicalTrials.gov Identifier: NCT00125021  
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Second Line Therapy
Gemcitabine Refractory
Pancreatic Cancer
Capecitabine
Tarceva
OSI-774
Metastatic Pancreatic Cancer

Study placed in the following topic categories:
Erlotinib
Capecitabine
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Neoplasm Metastasis
Endocrine System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:
Antimetabolites
Neoplasms
Neoplastic Processes
Antimetabolites, Antineoplastic
Neoplasms by Site
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009