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

Completed · Phase 2

Conditions studied: Metastatic Pancreatic Carcinoma

In brief

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

Key facts

Study ID

NCT00137761

Run by

Dana-Farber Cancer Institute

People needed

32

Starts

2004-10-01

Expected to finish

2009-03-01

Last updated by the study team

2009-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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