Clinical trial NCT00137761: Docetaxel in Combination With Iressa in Previously Treated Patients With Pancreatic Cancer
Official title: A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Pancreatic Carcinoma
Keywords: Pancreatic Carcinoma
Iressa
Docetaxel
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Beth Israel Deaconess Medical Center
name: Brigham and Women's Hospital
First posted: 2005-08-30
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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

Primary outcomes:
measure: To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy
timeFrame: 3 years
Secondary outcomes:
measure: To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Matthew Kulke, MD
role: PRINCIPAL_INVESTIGATOR
References: