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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2009-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Metastatic Pancreatic Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ZD 1839

Taken orally once daily

Intervention Type DRUG

Docetaxel

Given intravenously once weekly for 2 out of 3 weeks

Intervention Type DRUG

Other Intervention Names

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Iressa

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No