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Docetaxel in Combination With Iressa in Previously Treated Patients With 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.
 
ClinicalTrials.gov Identifier: NCT00137761
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : November 1, 2009
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute

Study Description
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Brief Summary:
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Carcinoma Drug: ZD 1839 Drug: Docetaxel Phase 2

Detailed Description:

Iressa will be taken orally once daily without interruption. Docetaxel will be administered intravenously once weekly for two out of every three weeks. Patients will also receive dexamethasone the night prior, morning of, and the evening after docetaxel treatment to help prevent an allergic reaction.

Every week that chemotherapy is given, blood tests and vital signs will be taken.

After the first 6 weeks of therapy a CT scan (or other radiological procedure) will be done to assess the progress of the disease. If the cancer is responding to the treatment and no unacceptable side effects have occured, treatment with Iressa and docetaxel will continue.

CT scans (or other radiological procedure) will be performed at week 12 and every 9 weeks thereafter to monitor the progress of the disease.

Study Design
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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 Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
Study Start Date : October 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : March 2009

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Arms and Interventions
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Intervention Details:
  • Drug: ZD 1839
    Taken orally once daily
    Other Name: Iressa
  • Drug: Docetaxel
    Given intravenously once weekly for 2 out of 3 weeks

Outcome Measures
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Primary Outcome Measures :
  1. To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel

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

Inclusion Criteria:

  • Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors); histologic confirmation of either the primary or metastatic site.
  • ECOG performance status of < 1
  • > 4 weeks since completion of previous chemotherapy
  • > 4 weeks since participation in any investigational drug study
  • Peripheral neuropathy of grade < 1
  • Patients must have failed a gemcitabine-containing regimen administered in the metastatic, adjuvant, or locally advanced setting.
  • Absolute neutrophil count (ANC) > 1,500/mm3
  • Hemoglobin > 9.0gm/dl
  • Platelets > 100,000/mm3
  • Total bilirubin < 2.0mg/dl
  • AST and alkaline phosphatase < 5 x upper limit of normal (ULN)
  • Albumin > 2.5gm/dl
  • CA 19-9 > 1.5 x ULN

Exclusion Criteria:

  • Prior therapy with taxane or with epidermal growth factor receptor (EGFR) inhibitors
  • More than one prior chemotherapy treatment
  • Clinically significant cardiac disease
  • Major surgery within 4 weeks of the start of study treatment
  • Evidence of central nervous system (CNS) metastases or carcinomatous meningitis or history of uncontrolled seizures, central nervous system disorders.
  • Uncontrolled serious medical or psychiatric illness
  • Pregnant or breast-feeding women
  • Other active malignancy
  • Inability to swallow tablets or evidence of a gastrointestinal malabsorption syndrome
  • Known severe hypersensitivity to Iressa
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort.
  • History of severe hypersensitivity reaction to drugs formulated with polysorbate 80
  • Any evidence of clinically active interstitial lung disease
  • Ascites requiring paracentesis
Contacts and Locations
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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): NCT00137761


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
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Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Matthew Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137761    
Other Study ID Numbers: 04-173
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: November 1, 2009
Last Verified: October 2009
Keywords provided by Dana-Farber Cancer Institute:
Pancreatic Carcinoma
Iressa
Docetaxel
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Docetaxel
 Gefitinib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors