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

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Metastatic Pancreatic Carcinoma

Treatments

Drug: Docetaxel

Drug: ZD 1839

Study type

Interventional

Funder types

Other

Identifiers

NCT00137761

04-173

Details and patient eligibility

About

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

Full 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.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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