- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137761
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, United States, 02115
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, United States, 02115
- Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Matthew Kulke, MD, Dana-Farber Cancer Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Protein Kinase Inhibitors
- Docetaxel
- Gefitinib
Other Study ID Numbers
- 04-173
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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