Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Massachusetts General Hospital Beth Israel Deaconess Medical Center Brigham and Women's Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00137761

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 II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Docetaxel ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer

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
Estimated Study Completion Date:	June 2009
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Taken orally once daily

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

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

Responsible Party:	Dana-Farber Cancer Institute ( Matthew Kulke, MD )
Study ID Numbers:	04-173
Study First Received:	August 26, 2005
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00137761
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Pancreatic Carcinoma
Iressa
Docetaxel

Study placed in the following topic categories:

Docetaxel
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Gefitinib
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009