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

Condition	Intervention	Phase
Metastatic pancreatic carcinoma	Drug: Iressa (ZD 1839)  Drug: Docetaxel	Phase II

Further Study Details: 

Primary Outcomes: To determine the response rate of iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy.
Secondary Outcomes: To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with iressa and docetaxel.
Expected Total Enrollment:  32

• 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.
• ANC > 1,500/mm3
• Hemoglobin > 9.0gm/dl
• Platelets > 100,000/mm3
• Total bilirubin < 2.0mg/dl
• AST and Alkaline phosphatase < 5 x ULN
• Albumin > 2.5gm/dl
• CA 19-9 > 1.5 x ULN

Exclusion Criteria:

• Prior therapy with taxane or with 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 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00137761

Matthew Kulke, MD      617-632-5136    matthew_kulke@dfci.harvard.edu
Carolyn Casey       carolyn_casey@dfci.harvard.edu

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States; Recruiting
      Massachusetts General Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Matthew Kulke, MD,  Principal Investigator,  Dana-Farber Cancer Institute   

Study ID Numbers:  04-173
Last Updated:  August 29, 2005
Record first received:  August 26, 2005
ClinicalTrials.gov Identifier:  NCT00137761
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-08-30