Study of Gemcitabine, Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Cholangiocarcinoma Clinical Trial

Official title:

Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948935
• Other study ID #: UPCC 06208
• Status: Completed
• Phase: Phase 2
• Start date: April 2009
• Est. completion date: September 26, 2014

Study information

• Verified date: March 2020
• Source: Abramson Cancer Center of the University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the combination chemotherapy with gemcitabine, irinotecan and panitumumab in patients with advanced biliary cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 26, 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• histologically or cytologically confirmed local advanced unresectable/metastatic adenocarcinoma of biliary tract

• measurable disease

• available tumor tissue for investigational immunohistochemical evaluations

• ECOG PS 0-2

• No prior chemotherapy, biologic therapy or radiation therapy

• Age Eighteen and older

• Lab values per protocol

Exclusion Criteria:

• Life expectancy less than three months

• Concurrent use of chemotherapy not indicated in the study protocol or any other investigational agents and patients who have received investigational drugs less than four weeks prior to enrollment

• Prior therapy, which affects or targets the EGF pathway

• Treatment for other carcinomas within the last five years, except cured non-melanoma skin and treated in-situ cervical cancer

• Recovery from major surgery within three weeks of the start of study treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Biliary Cancer
• Cholangiocarcinoma

Intervention

Drug:
• Gemcitabine, Irinotecan, Panitumumab
Gemcitabine 1000 mg/m2 over 100 minutes(Days 1, 8), irinotecan 100 mg/m2 IV over 60 minutes(days 1, 8) and panitumumab 9 mg/kg IV (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.

Locations

Country	Name	City	State
United States	Abramson Cancer Center at University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center of the University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival Rate at Five Months		5 months
Secondary	Response Rate From Combination Chemotherapy		5 months