Overview

This trial is active, not recruiting.

Conditions biliary cancer, cholangiocarcinoma
Treatment gemcitabine, irinotecan, panitumumab
Phase phase 2
Sponsor University of Pennsylvania
Start date April 2009
End date June 2013
Trial size 45 participants
Trial identifier NCT00948935, UPCC 06208

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Gemcitabine (Days 1, 8), irinotecan (days 1, 8) and panitumumab (day 1) every 3 weeks as a cycle. Continue until disease progression or unacceptable toxicities.
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.

Primary Outcomes

Measure
Progression free survival rate at five months
time frame: Outcome will be measured five months after last evaluable patient is entered on study.

Secondary Outcomes

Measure
Response rate from combination chemotherapy
time frame: Outcome will be measured five months after last evaluable patient is entered on study.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Combination of Gemcitabine (Fixed Dose-rate Infusion, FDR), Irinotecan and Panitumumab in Patients With Advanced and Metastatic Biliary Tract Adenocarcinoma
Trial information was received from ClinicalTrials.gov and was last updated in February 2013.
Information provided to ClinicalTrials.gov by University of Pennsylvania.