NCT00137761

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2004

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

November 2, 2009

Status Verified

October 1, 2009

Enrollment Period

2.7 years

First QC Date

August 26, 2005

Last Update Submit

October 30, 2009

Conditions

Metastatic Pancreatic Carcinoma

Keywords

Pancreatic CarcinomaIressaDocetaxel

Outcome Measures

Primary Outcomes (1)

  • To determine the response rate of Iressa and docetaxel in patients with advanced pancreatic cancer following failure of gemcitabine-based therapy

    3 years

Secondary Outcomes (1)

  • To determine the safety, radiologic response rate, progression-free survival and overall survival of patients treated with Iressa and docetaxel

Interventions

ZD 1839DRUG

Taken orally once daily

Also known as: Iressa
DocetaxelDRUG

Given intravenously once weekly for 2 out of 3 weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GefitinibDocetaxel

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Matthew Kulke, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2005

First Posted

August 30, 2005

Study Start

October 1, 2004

Primary Completion

June 1, 2007

Study Completion

March 1, 2009

Last Updated

November 2, 2009

Record last verified: 2009-10

Locations

US(3)