Metastatic Pancreatic Carcinoma Clinical Trial
Official title:
A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
Verified date | October 2009 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to find out what activity the combination of docetaxel and Iressa have against metastatic pancreatic cancer.
Status | Completed |
Enrollment | 32 |
Est. completion date | March 2009 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Dana-Farber Cancer Institute | Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy | 3 years | No | |
Secondary | To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel | TBD | Yes |
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