Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00243854
• Other study ID #: 0507-08 IUCRO-0130
• Status: Completed
• Phase: Phase 1
• First received: October 24, 2005
• Last updated: March 17, 2014
• Start date: November 2005
• Est. completion date: October 2011

Study information

• Verified date: March 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Other known NCT identifiers

• NCT00216307

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• metastatic disease or peritoneal seeding based on cross-sectional imaging

• previous irradiation to the planned field

• prior chemotherapy or immunotherapy

• active infection

• active PUD

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

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Indiana University Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

•   Indiana University Cancer Center website