Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00137761
First received: August 26, 2005
Last updated: October 30, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Metastatic Pancreatic Carcinoma
Drug: ZD 1839
Drug: Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel [ Time Frame: TBD ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: October 2004
Study Completion Date: March 2009
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ZD 1839
    Taken orally once daily
    Other Name: Iressa
    Drug: Docetaxel
    Given intravenously once weekly for 2 out of 3 weeks
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.

  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); 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137761

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
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
Principal Investigator: Matthew Kulke, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Matthew Kulke, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137761     History of Changes
Other Study ID Numbers: 04-173
Study First Received: August 26, 2005
Last Updated: October 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Pancreatic Carcinoma
Iressa
Docetaxel

Additional relevant MeSH terms:
Pancreatic Neoplasms
Carcinoma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014