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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Docetaxel; Gefitinib

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