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

Study Overview

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

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

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.

Metastatic Pancreatic Carcinoma

DRUG: ZD 1839
DRUG: Docetaxel

04-173

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
First Submitted 2005-08-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2009-10-30
First Submitted that Met QC Criteria 2005-08-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2009-11-01
First Posted (ESTIMATED) 2005-08-30	Results First Posted N/A	Last Verified 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/Arm	Intervention/Treatment

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

Secondary Outcome Measures	Measure Description	Time Frame
To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel

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:

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

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

Collaborators and Investigators

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

Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Investigators

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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Resources

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Clinical Trial Record