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

Phase 2

Completed

• Conditions: Biliary Cancer; Cholangiocarcinoma
• Interventions: Drug: Gemcitabine, Irinotecan, Panitumumab

• Registration Number: NCT00948935
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-15
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Primary Completion: 2014-09
• Study Completion: 2014-09-26
• Results First Submitted: 2019-04-16
• Results First Submitted QC: 2019-05-29
• Results First Posted: 2019-06-18
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chemotherapy	Gemcitabine, Irinotecan, Panitumumab	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.

Primary Outcome Measures

Name	Time	Method
Progression Free Survival Rate at Five Months	5 months

Secondary Outcome Measures

Name	Time	Method
Response Rate From Combination Chemotherapy	5 months

Trial Locations

Locations (1)

Abramson Cancer Center at University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States