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

October 30, 2009 updated by: Dana-Farber Cancer Institute

A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer

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

Study Overview

Status

Completed

Conditions

Metastatic Pancreatic Carcinoma

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Dana-Farber Cancer Institute
  - Boston, Massachusetts, United States, 02115
    - Beth Israel Deaconess Medical Center
  - Boston, Massachusetts, United States, 02115
    - Massachusetts General Hospital

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.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 years

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital

Beth Israel Deaconess Medical Center

Brigham and Women's Hospital

Investigators

Principal Investigator: Matthew Kulke, MD, Dana-Farber Cancer Institute

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 Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

August 26, 2005

First Submitted That Met QC Criteria