NCT00243854

Brief Summary

To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1 pancreatic-cancer

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 24, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 25, 2005

Completed
7 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 18, 2014

Status Verified

March 1, 2014

Enrollment Period

4.8 years

First QC Date

October 24, 2005

Last Update Submit

March 17, 2014

Conditions

Pancreatic Cancer

Keywords

Pancreatic CancerResectable Pancreatic Canceradenocarcinoma of the pancreas

Outcome Measures

Primary Outcomes (1)

  • To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy

    Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy

Interventions

TarcevaDRUG

Tarceva: 100mg/day x 2 weeks (Days 1-14) +

Eligibility Criteria

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

You may qualify if:

  • pathologically confirmed adenocarcinoma of the pancreas
  • resectable disease
  • tumor \</= 6cm diameter
  • ECOG performance 0-1
  • Organ system fxn: granulocytes (\>/=1800/uL); plt ct \>/=100K; bili\</=2mg; liver enzymes \<2.5ULN; crt \</=1.5;
  • Normal CXR
  • Negative pregnancy test

You may not qualify if:

  • metastatic disease or peritoneal seeding based on cross-sectional imaging
  • previous irradiation to the planned field
  • prior chemotherapy or immunotherapy
  • active infection
  • active PUD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Erlotinib Hydrochloride

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 Compounds

Study Officials

  • Higinia Cardenes, M.D., PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Gabriela Chiorean, M.D.

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2005

First Posted

October 25, 2005

Study Start

November 1, 2005

Primary Completion

August 1, 2010

Study Completion

October 1, 2011

Last Updated

March 18, 2014

Record last verified: 2014-03

Locations

US(1)