Status:
COMPLETED
Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Conditions:
Metastatic Pancreatic Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 nig...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00137761
Start Date
October 1 2004
End Date
March 1 2009
Last Update
November 2 2009
Active Locations (3)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115