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

Metastatic Pancreatic Carcinoma Clinical Trial

Official title:

A Phase II Study of Docetaxel in Combination With ZD 1839 (IRESSA) in Previously Treated Patients With Metastatic Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137761
• Other study ID #: 04-173
• Status: Completed
• Phase: Phase 2
• First received: August 26, 2005
• Last updated: October 30, 2009
• Start date: October 2004
• Est. completion date: March 2009

Study information

• Verified date: October 2009
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2009
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Carcinoma
• Pancreatic Neoplasms

Intervention

Drug:
• ZD 1839
Taken orally once daily
• Docetaxel
Given intravenously once weekly for 2 out of 3 weeks

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy		3 years	No
Secondary	To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel		TBD	Yes