search
Back to results

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

Primary Purpose

Metastatic Pancreatic Carcinoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ZD 1839
Docetaxel
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Carcinoma focused on measuring Pancreatic Carcinoma, Iressa, Docetaxel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital

Outcomes

Primary Outcome Measures

To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy

Secondary Outcome Measures

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

Full Information

First Posted
August 26, 2005
Last Updated
October 30, 2009
Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00137761
Brief Title
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
Official Title
A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
June 2007 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Carcinoma
Keywords
Pancreatic Carcinoma, Iressa, Docetaxel

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ZD 1839
Other Intervention Name(s)
Iressa
Intervention Description
Taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Given intravenously once weekly for 2 out of 3 weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Kulke, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs